subslover
2 years ago
Incannex Completes Positive Pre-IND Meeting with US FDA on IHL-216A for Treatment of Concussion and Traumatic Brain Injury
IXHL | 1 day ago
MELBOURNE, Australia, Oct. 11, 2022 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL) (‘Incannex’ or the ‘Company’), a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has completed a constructive pre-Investigational New Drug Application (‘pre-IND’) meeting with the U.S. Food and Drug Administration (‘FDA’) for its proprietary drug product IHL-216A for treatment of traumatic brain injury and concussion (‘TBI’).
IHL-216A is Incannex’s proprietary combination of cannabidiol (‘CBD’) and isoflurane (‘ISO’) that is being developed for treatment of TBI. Incannex submitted a pre-IND meeting package to the FDA in August 2022. The meeting package included a description of the unique formulation developed by Incannex, an overview of the proposed clinical development plan and specific questions Incannex submitted on the regulatory requirements for opening an Investigational New Drug application (‘IND’). Opening an IND is required to conduct trials in the United States and ensures that trials are designed to meet the data requirements necessary for FDA marketing approval.
In written correspondence, FDA provided valuable, multidisciplinary feedback on the proposed clinical development of IHL-216A and acknowledged that treatment of TBI is a significant unmet medical need that requires innovative treatment solutions. The FDA also confirmed that the FDA505(b)2 application was the appropriate regulatory pathway for IHL-216A, whereby some of the information required for marketing approval may derive from studies already completed on the drug components of IHL-216A and in the public domain.
FDA provided critical guidance on the data requirements for opening an IND for IHL-216A, particularly related to the intricacies of developing an inhaled drug product and conducting clinical trials that involve an anaesthetic. Incannex is drafting a follow-up request for additional information on the FDA’s recommendations and will provide an update to ASX and Nasdaq investor platforms when it has been received.
Chief Scientific Officer of Incannex, Dr. Mark Bleackley, said: “Feedback from the FDA in the pre-IND meeting indicated that the agency is highly interested in the development of IHL-216A for treatment of traumatic brain injury. Their responses covered all aspects of the proposed development and engaged a range of disciplinary experts that provided useful insight on all aspects of our development plan. The FDA has provided essential advice on inhaled drug development that will guide the most efficient development of IHL-216A.”
IHL-216A has demonstrated neuroprotective activity in two separate animal models of traumatic brain injury, one representing moderate to severe injury and the other representing mild injury, or concussion. In both models, treatment with IHL-216A improved the effects of injury to a greater extent that either CBD or ISO monotherapy.
In May of 2022, Incannex released the results of an extensive animal study that compared IHL-216A to its component drugs, CBD and ISO, in a model developed in collaboration with the U.S. National Football League (NFL). In that experiment, IHL-216A was observed to restore spatial memory after twenty-four hours in injured rodents whilst injured rodents that only received the vehicle as treatment did not display restored spatial memory.
This announcement has been approved for release to ASX by the Incannex Board of Directors.
About Incannex Healthcare Limited
Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of obstructive sleep apnoea (OSA), traumatic brain injury (TBI) and concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis, inflammatory bowel disease, anxiety disorders, addiction disorders, and pain, among other indications.
U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication under investigation currently has no, or limited, existing registered pharmacotherapy (drug) treatments available to the public and represent major global economic opportunities to Incannex and its shareholders.
Incannex has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners. The Company holds 19 granted patents and 29 pending patents. Incannex is listed on the Australian Stock Exchange (ASX) with stock code “IHL” and also has American Depository Shares listed on NASDAQ under code “IXHL”.
Website: www.incannex.com.au
Investors: investors@incannex.com.au
Forward-looking statements
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates, as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex's views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Incannex's views as of any date after the date of this press release.
Contact Information
Incannex Healthcare Limited
Mr Joel Latham
Managing Director and Chief Executive Officer
+61 409 840 786
joel@incannex.com.au
Investor Relations Contact – United States
Alyssa Factor
Edison Group
+1 (860) 573 9637
afactor@edisongroup.com
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jedijazz
2 years ago
News: Incannex announces positive results from phase 2 clinical trial investigating the effect of IHL-42X for treatment of obstructive sleep apnoea
NEWS PROVIDED BY Incannex Healthcare Limited $IXHL
Jun 03, 2022, 07:55 ET
Highlights:
IHL-42X reduced primary endpoint apnoea hypopnea index relative to baseline at all three doses that were assessed
Low dose IHL-42X exhibited superior safety and efficacy metrics to mid and high doses
Low dose IHL-42X reduced AHI by an average of 50.7% compared to baseline with 25% of participants experiencing a reduction in the apnoea hypopnea index of greater that 80%
Oxygen desaturation index was reduced by 59.7% relative to baseline while taking low dose IHL-42X, improving sleep quality and reducing cardiovascular stress
In low dose IHL-42X samples, THC concentrations in blood were well below the limits for impaired driving the morning after dose administration
IHL-42X was well tolerated – low dose IHL-42X was observed to have a lower number of total treatment emergent adverse events than placebo
Low dose IHL-42X reduced AHI substantially more effectively than is reported for the component active pharmaceutical ingredients, dronabinol and acetazolamide, as unregistered monotherapies.
MELBOURNE, Australia, June 3, 2022 /PRNewswire/ -- Incannex Healthcare Limited (NASDAQ: IXHL) (ASX: IHL), ('Incannex' or the 'Company') a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has completed analysis of data from the phase 2 proof-of-concept clinical trial investigating IHL-42X for treatment of obstructive sleep apnoea ('OSA'). IHL-42X reduced apnoea hypopnoea index ('AHI'), improved patient reported sleep quality and was well tolerated.
The clinical trial assessed three doses of IHL-42X at reducing the AHI in patients who suffered from OSA. Data was also collected for other aspects of sleep quality, THC clearance and safety. Trial participants received each of the three doses of IHL-42X and placebo across four seven-day treatment periods, separated by one week washout periods. At the end of each treatment period, they attended the clinic for an overnight sleep study where AHI was determined, along with other measures of sleep quality, quality of life and drug safety.
The study was conducted at the University of Western Australia Centre for Sleep Science and The Alfred Hospital. A total of eleven participants were recruited to the study and ten participants completed treatment periods. The crossover design of the study permitted Incannex to generate high quality data with a reduced participant number compared to a conventional parallel arm study. Each participant serves as their own internal control and inter-participant variation is eliminated. Data analysis was completed by Novotech, the contract research organisation responsible for management of the study, as well as the Incannex scientific research team, led by Chief Scientific Officer Dr Mark Bleackley. The findings of the clinical trial are presented below.
Effect of IHL-42X on apnoea hypopnoea index (AHI)
AHI is a measure of the number of times per hour a subject's airway is blocked (apnoea) or partially blocked (hypopnoea). It is the main criteria used to diagnose and monitor OSA. AHI data was collected during overnight polysomnography on night seven of the treatment periods.
All doses of IHL-42X reduced AHI in patients with sleep apnoea compared to baseline (Table 1). This reduction was substantially greater than observed for placebo.
At the group level the difference relative to baseline with low dose and medium dose was statistically significant (p<0.05)
When comparing directly to baseline within subjects the difference in AHI compared to baseline between all three doses and placebo was statistically significant (p<0.001) (Table 2)
Low dose IHL-42X reduced AHI by >50% relative to baseline in 62.5% of subjects and by >80% in 25% of subjects (Table 2).
Low dose IHL-42X reduced AHI to the greatest extent at both the group level and when comparing the within subject reduction relative to baseline
Low dose IHL-42X reduced AHI to a greater extent than predicted based on published data for dronabinol and acetazolamide alone (Table 3).
The reduction in AHI observed during IHL-42X treatment periods means that when treated with Incannex's proprietary drug, subject's breathing was interrupted less frequently during sleep. This supports Incannex's hypothesis that IHL-42X is an effective treatment for OSA. The observation that low dose IHL-42X was the most effective at reducing AHI is encouraging for the development of IHL-42X as a pharmaceutical as a lower dose will reduce risk of side effects and the cost of goods.
Furthermore, greater reduction in AHI with low dose IHL-42X compared to dronabinol and acetazolamide at equivalent doses supports Incannex's hypothesis that the two drugs are acting synergistically to reduce AHI and provides confidence that IHL-42X will meet the FDA's combination rule where both APIs must contribute to the therapeutic effect of a fixed dose combination product.
Table 1. Average AHI data for baseline and each treatment period
Baseline
Placebo
Low
Medium
High
Average AHI
42.84
40.08
21.13
22.22
27.78
Standard deviation
20.33
18.16
15.92
15.52
17.61
% Reduction relative to baseline
N/A
6.44
50.69
48.13
35.16
p value compared to baseline
N/A
0.76
0.029
0.031
0.12
Table 2. Change in AHI from baseline within subject (least square mean)
Average change
in AHI from
baseline
p-value relative
to placebo
(Bonferroni
adjusted)
Proportion of subjects
with AHI reduction
>50% relative to
baseline (%)
Proportion of subjects
with AHI reduction
>80% relative to
baseline (%)
Placebo
1.95
N/A
10
0
Low
17.51
<0.001
62.5
25
Medium
14.86
<0.001
33.3
11.1
High
16.18
<0.001
22.2
11.1
Table 3. Comparison of reduction in AHI relative to baseline with low dose IHL-42X and the predicted reduction with component drugs as monotherapies at equivalent doses based on reported data.
Reduction in AHI compared to baseline (%)
2.5 mg dronabinol (1)
23.4
125 mg acetazolamide (2)
23.4
Low dose IHL-42X
50.7
Effect of IHL-42X on oxygen desaturation index (ODI)
Oxygen desaturation index ('ODI') is the number of episodes of oxygen desaturation per hour of sleep, with oxygen desaturation defined as a decrease in blood oxygen saturation (SpO2) to lower than 3% below baseline. Reduced oxygen uptake is a key component of the pathology of OSA and contributes to daytime sleepiness and the long-term health consequences associated with OSA. ODI data was collected during overnight polysomnography on night seven of the treatment periods.
All three doses of IHL-42X reduced ODI compared to baseline to a greater extent than placebo.
For low and medium dose IHL-42X the difference in reduction in ODI relative to baseline compared to placebo was statistically significant (p<0.05)
The greater reduction in ODI during IHL-42X treatment periods compared to placebo means that there is more oxygen in the subject's blood during sleep while taking IHL-42X. This improves sleep quality and reduces risks of oxidative stress, bursts of the stress hormone cortisol, insulin resistance, altered metabolism and cardiovascular disease.
Table 4. Reduction in ODI compared to baseline during each treatment period.
Reduction in ODI relative to
baseline (least squares mean)
Reduction in ODI
relative to baseline
(%)
p value compared to
placebo (Bonferroni
adjusted)
Placebo
1.8
18.3
N/A
Low
11.7
59.7
0.021
Medium
12
59.0
0.012
High
8.32
28.5
0.162
Plasma THC levels the morning after IHL-42X dosing
Countries that have set limits for THC above which driving is illegal have set those limits at 1-2 ng/mL (3-6). It is important to understand the clearance of THC after dosing with IHL-42X to determine where there will be an impact on ability to drive in countries where THC limits are in place. Plasma samples were collected 2 hours post dose 1 and the morning after dose 7 for each treatment period. Samples were analysed for concentration of THC using liquid chromatography with tandem mass spectrometry (LC-MS-MS).
The morning after dose 7, THC levels in the low dose IHL-42X samples had an average of 0.20 ng/mL and a maximum of 0.45 ng/mL. Both of which are below the thresholds for impaired driving. With medium and high dose IHL-42X the average THC concentrations the morning after dose 7 were 0.86 and 0.52 respectively.
Effect of IHL-42X on patient reported sleep quality
Each morning of the clinical trial, subjects recorded their sleep quality for the previous night as very poor, poor, fair, good, or very good. To compare patient reported sleep quality, the proportion of subjects who reported good or very good sleep each night was averaged across each treatment period. During the IHL-42X treatment periods subjects more frequently reported that their sleep quality was good or very good than placebo. The highest level of patient reported sleep quality was observed with low and high dose IHL-42X (Table 5).
Table 5. Patient reported sleep quality during each treatment period
Proportion of subjects reporting good or very good sleep quality
Placebo
26.50%
Low
49.49%
Medium
38.47%
High
50.13%
Sleep metrics captured by actigraphy
For the duration of the clinical trial, subjects wore an Actiwatch, a watch-like device that uses actigraphy to capture data on activity and sleep. IHL-42X at all doses improved sleep efficiency (what percentage of time in bed a subject is asleep), the number of awakenings per night, and the total minutes the subject was awake during the night (WASO) compared to placebo (Table 6). These improvements were greatest for low and high dose IHL-42X. This means that while taking IHL-42X subjects were asleep for a greater proportion of time they were in bed and woke up less often.
Table 6. Sleep metrics captured by actigraphy
Placebo
Low
Medium
High
Sleep efficiency
average
76.83
84.81
81.34
84.17
p value compared to placebo
N/A
0.0048
0.058
0.0078
Awakenings per night
average
49.31
35.8
41.44
37.33
p value compared to placebo
N/A
0.0053
0.055
0.012
WASO (min)
average
62.59
37.55
47.22
38.55
p value compared to placebo
NA
0.00011
0.0031
0.0010
Safety considerations
Adverse events were recorded from the time the subjects enrolled in the trial until their end of study visit. After recording of treatment emergent adverse events (TEAE) the study team, including investigators and medical monitors, reviewed the TEAEs to determine whether they were likely related to the investigational product. The TEAEs were consistent with what has been reported for dronabinol and acetazolamide alone. For each treatment period the proportion of subjects reporting one or more TEAEs (Table 7) as well as the total number of TEAEs (Table 8) were extracted from the clinical study report. Low dose IHL-42X had a similar proportion of subjects reporting TEAEs and a lower number of total TEAEs than placebo. This indicated that low dose IHL-42X is well tolerated.
Table 7. Proportion subjects of TEAEs reported for each treatment period
Placebo
Low
Medium
High
Total TEAE (%)
81.8
33.3
55.6
66.7
Related TEAE (%)
27.3
22.2
44.4
55.6
Table 8. Total number of TEAEs reported during each treatment period
Placebo
Low
Medium
High
Total TEAE
15
6
22
16
Related TEAE
7
4
16
12
References:
Carley DW, Prasad B, Reid KJ, Malkani R, Attarian H, Abbott SM, Vern B, Xie H, Yuan C, Zee PC. 2018. Pharmacotherapy of apnea by cannabimimetic enhancement, the PACE clinical trial: Effects of dronabinol in obstructive sleep apnea. Sleep 41.
Schmickl CN, Landry SA, Orr JE, Chin K, Murase K, Verbraecken J, Javaheri S, Edwards BA, Owens RL, Malhotra A. 2020. Acetazolamide for OSA and central sleep apnea: a comprehensive systematic review and meta-analysis. Chest 158:2632–2645.
https://www.justice.gc.ca/eng/cj-jp/sidl-rlcfa/qa2-qr2.html
Vindenes, V., et al., (2012) Impairment based legislative limits for driving under the influence of non-alcohol drugs in Norway, Forensic Science International 219(1-3,)1-11
Wolff, K, et al., Driving Under the Influence of Drugs: Report from the Expert Panel on Drug Driving, Department of Transport, London, 2013.
https://www.vifm.org/wp-content/uploads/VIFM-Annual-Report-2019-2020.pdf
This announcement has been approved for release to ASX by the Incannex board of directors.
About Incannex Healthcare Limited
Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of anxiety disorders, obstructive sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease. U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication represents major global markets and currently have no, or limited, existing registered pharmacotherapy (drug) treatments available to the public.
Incannex has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners. Incannex is listed on the Australian Stock Exchange (ASX) with stock code "IHL" and also has American Depository Shares listed on NASDAQ under code "IXHL".
Website: www.incannex.com.au
Investors: investors@incannex.com.au
Forward-looking statements
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates, as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex's views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Incannex's views as of any date after the date of this press release.
Contact Information
Incannex Healthcare Limited
Mr Joel Latham
Managing Director and Chief Executive Officer
+61 409 840 786
joel@incannex.com.au
US IR Contact
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
SOURCE Incannex Healthcare Limited
jedijazz
2 years ago
NEWS: $IXHL Incannex Announces Positive Pre-IND Meeting with U.S. FDA for IHL-42X for Obstructive Sleep Apnoea
Tue, May 17, 2022, 7:55 AM
MELBOURNE, Australia, May 17, 2022 /PRNewswire/ -- Incannex Healthcare Limited (NASDAQ: IXHL) (ASX: IHL), ('Incannex' or the 'Company') a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it completed a highly constructive Pre-Investigational New Drug Application ('pre-IND') meeting with the U.S. Food and Drug Administration ('FDA') to discuss the development IHL-42X.
IHL-42X is a fixed dose combination of dronabinol and acetazolamide that is being developed as a treatment for obstructive sleep apnoea ('OSA') in adults. Incannex submitted a pre-IND meeting package and meeting request to the FDA in February 2022. The meeting package included an overview of the development program, and specific questions Incannex had on the regulatory requirements for opening an investigational new drug ('IND') application. Opening an IND is required to conduct clinical trials in the U.S and ensures that trials are designed so that they meet the data requirements necessary for FDA marketing approval.
The written responses, and the responses provided in a teleconference with FDA representatives, were constructive and supportive, with interest in the project underpinned by the significant cohort of people diagnosed with OSA and the absence of pharmacological treatment solutions.
FDA provided guidance on Incannex's proposed long-term development strategy, including specific parameters to demonstrate safety and efficacy in phase 2 and 3 pivotal studies. Guidance provided by the FDA to the Company will inform adjustments to the clinical trial protocols to ensure that they generate the data required for a 505(b)(2) new drug application (NDA).
In a decision that will save Incannex time and cost, FDA agreed that Incannex does not need to conduct studies in animals. In particular, the agency confirmed that animal toxicology and animal pharmacokinetic (PK) studies are not required for opening an IND for IHL-42X. Therefore, the next step for the development of IHL-42X will be the adjustment of clinical trial designs and arrangement of operational imperatives necessary to open an IND with FDA.
Chief Scientific Officer for Incannex, Dr Mark Bleackley, said: "The FDA's interest in IHL-42X as a potential therapy for OSA was extremely encouraging. The feedback they provided on the overall proposed development program was positive. The agency's responses to the specific questions we posed allow us to revise our clinical trial protocols, to ensure that we are running highly efficient studies that generate the type and amount of data the FDA will require in a future marketing application. The results from the pre-IND meeting will shape the IHL-42X development program over the coming months."
Incannex completed a phase 2 proof of concept clinical trial in 2021 to assess IHL-42X in patients with OSA. Preliminary results from the trial have been published, showing that 60% of trial participants experienced a reduction in apnea-hypopnea index ('AHI') of greater than 55% during at least one treatment compared to baseline. 20% of trial participants experienced a reduction in AHI of greater than 80%. The complete clinical study report is anticipated to be released in June 2022.
This announcement has been approved for release to ASX by the Incannex board of directors.
About Incannex Healthcare Limited
Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for the treatment of anxiety disorders, obstructive sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease. U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication represents major global markets and currently have no, or limited, existing registered pharmacotherapy (drug) treatments available to the public.
Incannex has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners. Incannex is listed on the Australian Stock Exchange (ASX) with stock code "IHL" and also has American Depository Shares listed on NASDAQ under code "IXHL".
Website: www.incannex.com.au
Investors: investors@incannex.com.au
Forward-looking statements
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates, as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex's views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Incannex's views as of any date after the date of this press release.
Contact Information
Incannex Healthcare Limited
Mr Joel Latham
Managing Director and Chief Executive Officer
+61 409 840 786
joel@incannex.com.au
US IR Contact
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/incannex-announces-positive-pre-ind-meeting-with-us-fda-for-ihl-42x-for-obstructive-sleep-apnoea-301548749.html
jedijazz
2 years ago
News: Incannex announces IHL-216A observed to have a neuroprotective effect in a rodent model of sports concussion; rapidly restores spatial memory post-concussion
Tue, May 10, 2022, 7:55 AM
Highlights:
The study compared IHL-216A to its component drugs, cannabidiol (CBD) and isoflurane, in a model developed in collaboration with the US National Football League (NFL)
IHL-216A restored spatial memory after twenty-four hours in injured rodent models whilst those that only received the vehicle as treatment did not have restored spatial memory
Treatment with CBD only partially restored spatial memory compared to IHL-216A, further supporting the benefits of Incannex's patented novel drug combination compared to CBD alone
Incannex now targets a pre-IND meeting with the U.S. FDA in Q3 2022 to discuss an expedited clinical trial program.
MELBOURNE, Australia, May 10, 2022 /PRNewswire/ -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), ('Incannex" or the 'Company'), a clinical stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, today announced that IHL-216A was observed to have a strong neuroprotective effect in a widely known model of sports concussion.
The preclinical study compared IHL-216A to its component drugs, cannabidiol ('CBD') and isoflurane, in a rodent model of sports concussion that was developed in collaboration with the US National Football League (NFL) to accurately represent the type of brain injury that occurs in sports related concussion (1, 2). This study compared six groups of twenty-four Sprague Dawley rats and the treatment groups are listed in Table 1 on page 4.
When animals were tested in a Y-maze task, which assesses spatial memory by determining the animal's ability to discriminate between a novel (new) and familiar arm, twenty-four hours after injury, animals treated with IHL-216A were found to have no difference in discrimination index compared to sham (uninjured) animals (mean difference= 0.0598, p=0.5855) (Figure 1).
In contrast, injured animals treated with either vehicle or isoflurane alone after injury, the discrimination index was significantly reduced compared to sham animals (mean diff=0.2704, p=0.0498 and mean diff=0.3095, p=0.0245 respectively). The group treated with CBD alone had intermediate performance in the Y-maze between sham and vehicle treated animals (mean diff.0.1745, p=0.2933). These findings indicate that the defect in spatial memory observed at 1 day post injury is restored in animals treated with IHL-216A.
The study was conducted at the Department of Neuroscience, Monash University. In this model, concussions experienced by NFL players have been scaled to Sprague Dawley rats, according to known biological relationships, to mimic the collision mechanics including high velocity impact and head acceleration. The injury is induced using a custom-built device, which provides one of the best-known simulations of sports concussion currently available in a rodent model.
Figure 1. IHL-216A restores the deficit in Y-maze novel/familiar arm discrimination index assessment 24 h post TBI. A Y-maze was used to assess spatial memory 24 h after induction of TBI. Sham + Vehicle treated animals displayed a clear preference for the novel arm. This preference was reduced in TBI + vehicle animals, indicating that there is a deficit in novel arm discrimination associated with TBI. 10 Each group consisted of 24 rodents.
Figure 1. IHL-216A restores the deficit in Y-maze novel/familiar arm discrimination index assessment 24 h post TBI. A Y-maze was used to assess spatial memory 24 h after induction of TBI. Sham + Vehicle treated animals displayed a clear preference for the novel arm. This preference was reduced in TBI + vehicle animals, indicating that there is a deficit in novel arm discrimination associated with TBI. 10 Each group consisted of 24 rodents.
More
The findings from this study further support the protective effect of IHL-216A in traumatic brain injury and expands upon the initial animal study conducted by Incannex in 2020, the results of which were released on the 15th of December 2020 in the announcement titled, "Positive results from IHL-216A TBI/concussion study."
Following current and previous positive preclinical observations, Incannex has commenced preparation of a pre-Investigational New Drug (IND) meeting package for IHL-216A. The study team is targeting a pre-IND meeting with the U.S. Food and Drug Administration ('FDA') in Q3 2022 to discuss the Company's intention to conduct an expedited clinical trial program required for a new drug application and marketing approval.
Chief Scientific Officer of Incannex Healthcare, Dr. Mark Bleackley, said; "It is exciting that we have observed a neuroprotective effect for IHL-216A in an animal model that replicates injuries observed in sports concussion. Combining the results from our two animal studies indicates that IHL-216A has the potential to be effective at reducing the effects of traumatic brain injuries across the spectrum of injury severity. The data also gives us the confidence to proceed to clinical development, the first step of which is preparing for a pre-IND meeting with the FDA to get confirmation that our proposed clinical development strategy is acceptable."
About IHL-216A
IHL-216A is a combination drug that combines cannabidiol ('CBD') with any volatile anaesthetic agent, including isoflurane. IHL-216A has been designed to be administered soon after head trauma to reduce secondary brain injuries that lead to neurological deficits. Due to the product's potential therapeutic utility in contact sports, IHL-216A is designed to satisfy World Antidoping Authority (WADA) and Australian Anti-Doping Authority's (ASADA) specifications for use by athletes at risk of TBI and Chronic Traumatic Encephalopathy, otherwise known as CTE.
About Traumatic Brain Injury and Concussion
Sixty-nine million people are estimated to incur a TBI every year (3). There are currently no registered pharmaceutical agents approved for the treatment of TBI. Current treatment strategies for TBI range for rest in minor TBI and concussion to surgical interventions to deal with hematomas in severe TBI (4).
This announcement has been approved by the Board.
About Incannex Healthcare Limited
Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of generalised anxiety disorder (GAD), obstructive sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease. U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication represents major global markets and currently have no, or limited, existing registered pharmacotherapy (drug) treatments available to the public. IHL has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners.
Website: www.incannex.com.au
Investors: investors@incannex.com.au
Forward-looking statements
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates, as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex's views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information, future events or otherwise. These forward- looking statements should not be relied upon as representing Incannex's views as of any date after the date of this press release.
Contact Information
Incannex Healthcare Limited
Mr Joel Latham
Managing Director and Chief Executive Officer
+61 409 840 786
joel@incannex.com.au
US IR Contact
Rx Communications Group Michael Miller
+1-917-633-6086
mmiller@rxir.com
jedijazz
2 years ago
$IXHL Incannex Completes Loyalty Option Program to Raise A$23.6M; Current Cash at Bank is Approximately A$40.0M
MELBOURNE, Australia, April 28, 2022 /PRNewswire/ -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), ('Incannex' or the 'Company') a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, today announced that it has finalised its loyalty option offer to shareholders to raise A$23.6M.
Loyalty options expired on April 22, 2022 and a total of 67.3M new shares are to be issued shortly as a result of the entitlement program. For every two (2) new shares that will be issued, one (1) piggy-back option will be granted to participants.
Piggy-back options will be issued shortly and have an exercise price of A$1.00 (equivalent to approx. US$18.25 per ADS on Nasdaq), expiring April 28, 2023. A total of 33.7M piggy-back options will be issued and Incannex does not intend to seek approval to list the piggy-back options on ASX or NASDAQ.
The Directors of Incannex collectively hold 175.9M shares in the Company and permitted their entitlement of approximately 11.7M shares, representing A$4.1M in investment capital, to be allocated to a strategic investor group that intend to enhance liquidity via the company's ADS program on the NASDAQ exchange.
The additional capital will primarily be allocated to clinical research and development activities that are significantly ramping up in 2022 and 2023.
This announcement has been approved for release to ASX by the Incannex board of directors.
About Incannex Healthcare Limited
Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for the treatment of anxiety disorders, obstructive sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease. U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication represents major global markets and currently have no, or limited, existing registered pharmacotherapy (drug) treatments available to the public. IHL has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners.
Website: www.incannex.com.au
Investors: investors@incannex.com.au
Forward-looking statements
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates, as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex's views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Incannex's views as of any date after the date of this press release.
Contact Information
Incannex Healthcare Limited
Mr Joel Latham
Managing Director and Chief Executive Officer
+61 409 840 786
joel@incannex.com.au
US IR Contact
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
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