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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
September 3, 2024
PRAXIS PRECISION MEDICINES, INC.
(Exact name of registrant as specified in its
charter)
Delaware |
001-39620 |
47-5195942 |
(State or other jurisdiction
of incorporation) |
(Commission
File Number) |
(I.R.S. Employer
Identification No.) |
Praxis Precision Medicines, Inc.
99 High Street, 30th Floor
Boston, Massachusetts 02110
(Address of principal executive offices, including
zip code)
(617) 300-8460
(Registrant’s telephone number, including
area code)
Not Applicable
(Former Name or Former Address, if Changed Since
Last Report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trade
Symbol(s) |
|
Name of each exchange
on which registered |
Common Stock, $0.0001 par value per share |
|
PRAX |
|
The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate
by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 7.01. Regulation FD Disclosure.
On September 3, 2024, Praxis Precision Medicines, Inc.
(the “Company”) published a corporate presentation announcing topline results from its EMBOLD Study. The presentation is available
in the “Investors + Media” portion of the Company's website at investors.praxismedicines.com and a copy is furnished as Exhibit 99.1
to this Current Report on Form 8-K.
The information in this Item 7.01 of this Form 8-K
and Exhibit 99.1 attached hereto shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall any of it be deemed incorporated
by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in
such a filing.
Item 8.01. Other Events.
On September 3, 2024, the Company announced
topline results from the EMBOLD study evaluating relutrigine (PRAX-562) in SCN2A and SCN8A developmental and epileptic encephalopathy
(DEE) patients.
EMBOLD is a multicenter, double-blind, placebo-controlled,
intervention-period-masked, randomized study, followed by open-label extension (OLE), which enrolled eligible male and female participants
aged 2-18 years with a diagnosis of early onset SCN2A-DEE or SCN8A-DEE. Sixteen patients were randomized (1:1) to receive
relutrigine QD for 16 weeks, or relutrigine QD for 12 weeks and matching placebo QD for 4 weeks, administered orally or via gastrostomy/jejunostomy
tube (G/J-tube). Fifteen patients were determined to be eligible for efficacy assessments. Dose adjustment was permitted to a maximum
of 1.0 mg/kg/day and a minimum of 0.25 mg/kg/day. Thirteen patients enrolled in the OLE.
Summary of EMBOLD results
Relutrigine was generally safe and well tolerated
by patients during the EMBOLD study. Seven patients increased the daily dose from 0.5 to 1 mg/kg/day during the double-blind period of
the study. No patient required dose reduction. The most common adverse events (AE) were infections, vomiting, pyrexia, somnolence and
constipation in patients receiving relutrigine. No patients discontinued due to an AE.
Patients on relutrigine observed a placebo-adjusted reduction
of 46% in countable motor seizures (log-transformed). Change in Global Impression of Improvement,
assessed by the caregiver and clinician at week 16 for patients on relutrigine, showed an improvement (caregiver, clinician) in disruptive
behavior (29%, 23%), communication (43%, 31%), seizure severity and intensity (71%, 62%) and alertness (57%, 69%).
Eight patients have completed at least one 28-day period in the long-term
extension of EMBOLD with a median reduction in motor seizures of 75%. Five patients achieved a 28-day seizure free status while receiving
relutrigine, compared to none on placebo.
Forward-Looking Statements
This Current Report on Form 8-K contains
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws,
including statements regarding the clinical development of relutrigine, including with respect to the EMBOLD and related long-term extension
study, and the potential benefits of relutrigine to treat patients aged 2-18 years with a diagnosis of early onset SCN2A-DEE or SCN8A-DEE.
The forward-looking statements included in this Current Report on Form 8-K are subject to a number of risks, uncertainties and assumptions,
including, without limitation, uncertainties inherent in clinical trials, the expected timing of submission for regulatory approval or
review by governmental authorities and other risks as described in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2023 and its other filings with the Securities and Exchange Commission. These statements are based only on facts currently
known by the Company and speak only as of the date of this Current Report on Form 8-K. As a result, you are cautioned not to rely
on these forward-looking statements and the Company undertakes no obligation to publicly update or revise any forward-looking statement,
whether as a result of new information, future developments or otherwise.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
PRAXIS
PRECISION MEDICINES, INC. |
|
|
|
Date:
September 3, 2024 |
By: |
/s/
Marcio Souza |
|
|
Marcio
Souza |
|
|
Chief
Executive Officer |
Exhibit 99.1
| RELUTRIGINE: EMBOLD Phase 2 Study Topline Results
September 3, 2024
® |
| 2
Forward-looking statements
This presentation may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations, and financial
conditions, including but not limited to express or implied statements regarding the current beliefs, expectations and assumptions regarding the future of our business, future plans and
strategies, , including statements regarding the estimated market for our product candidates, if approved, our development plans, our preclinical and clinical results, including statements
regarding the clinical development of relutrigine and the EMBOLD and related long-term extension study, and the potential benefits of relutrigine to treat patients aged 2-18 years with a
diagnosis of early onset SCN2A-DEE or SCN8A-DEE, as well as the potential benefit to well-being and quality of life, the timing of the EMERALD study, any upcoming discussions with the FDA, and
the timing thereof, and the safety, efficacy, and regulatory and clinical design or progress, potential regulatory submissions, approvals and timing thereof of any of our product candidates. Any
forward-looking statements in this presentation are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may
cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this presentation, including, without limitation, risks relating to:
(i) the success and timing of our ongoing clinical trials, (ii) the success and timing of our product development activities and initiating clinical trials, (iii) the success and timing of our collaboration
partners’ product development activities, (iv) the timing of and our ability to obtain and maintain regulatory approval of any of our product candidates, (v) our plans to research, discover and
develop additional product candidates, (vi) our ability to enter into collaborations for the development of new product candidates, (vii) our ability to establish manufacturing capabilities, and our
collaboration partners’ abilities to manufacture our product candidates and scale production, (viii) our ability to meet any specific milestones set forth herein, and (ix) the potential addressable
market sizes for product candidates. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Except as required by applicable law,
we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, readers
are cautioned not to place undue reliance on these forward-looking statements.
For further information regarding the risks, uncertainties and other factors that may cause differences between our expectations and actual results, you should review the “Risk Factors” section of
our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (“SEC”) and our other filings with the SEC.
Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and
research. While we believe these third-party sources to be reliable as of the date of this presentation, we have not independently verified, and make no representation as to the adequacy, fairness,
accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this presentation involves a number of assumptions and limitations,
and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while we believe our own internal research is reliable, such research has not been verified by any
independent source. |
| 3
Relutrigine - EMBOLD delivers unparalleled results in DEE
46% placebo-adjusted seizure
reduction
Unprecedented level of
seizure freedom
5 patients seizure-free
for longer than 28 days
Well-tolerated in a
heavily treated
population
75% long-term
median seizure
reduction
Disease
modifying impact
for patients
assessed by
clinicians and
caregivers
Initiated an
expanded
registration
cohort |
| 4
>$500M
US Market Opportunity
* Poke G, Stanley J, Scheffer IE, Sadleir LG. Epidemiology of Developmental and Epileptic Encephalopathy and of Intellectual Disability and Epilepsy in Children
>100k
Developmental Epilepsies with high
seizure burden using sodium channel
blockers*
>$2B+
Opportunity for DEEs
~5K SCN2/8A
US patients
Relutrigine
Addressable Patients Peak Revenue Potential
Relutrigine is poised to disrupt the DEE market |
| 5
Disease Overview:
Developmental and Epileptic
Encephalopathies (DEEs)
RELUTRIGINE |
| 6
DEEs are demanding and devastating with early mortality
The incidence of DEE is expected to be 1/10,000 live births
Characterized by frequent seizures,
abnormal brain function, and
developmental disability, typically
beginning in infancy
Often caused by mutations that
disrupt function of brain voltage-gated
ion channels
Significantly impact quality of life for
both patients and their caregivers
Patients experience impairment in
motor, cognitive and language
development, with many remaining
non-verbal
Treatment is sub-optimal, often
associated with safety and
tolerability issues
Rarely survive beyond teenage years,
with SUDEP and aspiration
pneumonia amongst common causes
of early mortality
1. Zuberi SM, et al. Epilepsia. 2022;63(6):1349-1397 2. Helbig KL, et al. Am J Hum Genet. 2018;103(5):666-678. , 3. Takai A, et al. Int J Mol Sci.
2020;21(17):6442, 4. Gallop K, et al. Epilepsy Behav. 2021;124:108324, 5. Johannessen Landmark C, et al. Epilepsia. 2021;62(4):857-873. 6. Thurman DJ, et al.
Epilepsia. 2014;55(10):1479-1485 |
| 7
• SCN2A and SCN8A conditions are caused by mutations in ion
channels that disrupt normal function
• Patients with SCN2A and SCN8A DEEs frequently exhibit
symptoms from birth, persisting their entire life, including:
• Severe and uncontrollable early-onset seizures
• Movement disorders
• Pronounced global developmental delays and marked
intellectual disabilities
• Devastating quality of life, including on their caregivers
• Refractory to treatment
• Life-expectancy is significantly shortened, rarely surviving
beyond teenage years
SCN2A and SCN8A are amongst the most severe and refractory forms of DEE
Estimated prevalence of ~5,000 patients in the US
1. Source: Invitae Behind The Seizure Data; Ambit Genetic Testing and Claims Data Analysis. 2. Kim JB. Korean J Pediatr. 2014;57(1):1-18 3. SCN2A-related disorders. Children’s Hospital
of Philadelphia. Accessed Aug 27, 2024. https://www.chop.edu/conditions-diseases/scn2a-related-disorders |
| 8
RELUTRIGINE
Mechanism of Action |
| 9
Preclinical and emerging clinical data demonstrate relutrigine has the potential to
be a first- and best-in-class small molecule for DEEs
Superior selectivity for disease-state NaV channel
hyperexcitability
Convenient auto-titration regimen with stable PK
Unprecedented therapeutic window with potential
for superior safety and efficacy
RELUTRIGINE
FORMULATED FOR
PEDIATRIC USE
FUNCTIONAL STATE
MODULATOR |
| 10
% INHIBITION OF hNaV1.6 PERSISTENT INa COMPARISON OF POTENCY AND SELECTIVITY
Superior potency and selectivity for disease-state NaV channel hyperexcitability
0.01 0.1 1 10 100 1000 10000
0
20
40
60
80
100
Concentration (µM)
% Inhibition
Carbamazepine
Lamotrigine
Cenobamate
Relutrigine Persistent INa
IC50 (nM)
Ratio of persistent to
peak inhibition
Relutrigine 141 60
Carbamazepine 77,520 30
Cenobamate 73,263 23
Lidocaine 68,230 19
Lamotrigine 78,530 16
Lacosamide 833,100 n/a*
Valproic Acid <10% @ 1 mM No inhibition
MORE
SELECTIVE
HIGHER
POTENCY |
| 11
MES EFFICACY sLMA TOLERABILITY
Functional selectivity translates to a wide therapeutic index in vivo for relutrigine
Therapeutic Index (TI) = TC50 / EC50
CD-1 mice; (n=12/group)
**p<0.01 vs. Veh
ED50: 2 mg/kg
Molecule
Plasma
Therapeutic Index
Relutrigine 16.2x
Relutrigine (mg/kg, PO) Relutrigine (mg/kg, PO) CD-1 mice; (n=20/group)
ANOVA/Dunnett
**p<0.01 vs. Veh
TD50: 44 mg/kg
Veh 0.3 1 3 10
0
20
40
60
MES Latency (sec)
**
**
Veh 10 20 40
0
10000
20000
30000
40000
50000
60000
70000
Total DIstance Travelled (mm)
**
** |
| 12
Topline Data
RELUTRIGINE |
| 13
KEY ENDPOINTS:
Incidence and severity of treatment-emergent
adverse events (TEAEs)
Change from baseline in monthly (28-day) motor
seizure frequency
Seizure freedom achieved for a 4-week period
Clinical and Caregiver Global Impression of
Improvement and Severity
Relutrigine Phase 2 EMBOLD study design and endpoints
* Participants receive either 0.5 mg/kg/day relutrigine QD for 16 weeks or 0.5 mg/kg/day relutrigine QD for 12 weeks & matching placebo QD for 4 weeks. Participants in the
relutrigine/placebo arm will receive placebo for 4 consecutive weeks during the 16-week treatment period, with timing of placebo administration blinded for both participants and
investigator. Dose adjustment is permitted to a max of 1.0 mg/kg/day and a min of 0.25 mg/kg/day.
DOUBLE-BLIND TREATMENT PERIOD
(4 x 4-week periods => 16 WEEKS)
Relutrigine
1:1
Randomization
and Baseline
N=16
(SCN2A/SCN8A)
OLE
TREATMENT
PERIOD
(48 WEEKS)
Relutrigine for 4 x 4 weeks
0.5 mg/kg/day
Placebo for 1 x 4 weeks
Relutrigine for 3 x 4 weeks*
0.5 mg/kg/day |
| 14
EMBOLD study disposition
*Patients assigned to placebo received placebo for one (4 week) period and relutrigine for 3 periods
**1 patient had no available data for efficacy assessment
Assessed for eligibility
(n=21)
Did not meet inclusion
criteria (n=5)
Placebo (n=8)*
• Safety population (n=8)
• Eligible for assessment (n=7**)
Relutrigine (n=8->16*
)
• Safety population (n=16)
• Eligible for assessment (n=15**)
Assessed for baseline
(n=16)
Pre-screened for
eligibility (n=74)
Key Inclusion Criteria
• Documented severe DEE with mutations
in SCN2A or SCN8A genes
• Age 2-18 years
• ≥8 countable motor seizures in 4 weeks
preceding AND during 28-day baseline
observation
• On stable ASM doses for ≥1 month prior
to screening |
| 15
Demographics and Baseline Characteristics
Placebo
(n = 8)
Total
(n = 16)
Age, mean (min, max) 6.1 (3, 12) 5.9 (2, 14)
DEE
SCN2A, n (%) 4 (50) 7 (44)
SCN8A, n (%) 4 (50) 9 (56)
Gender (Male / Female, %) 5/3 (63/37) 9/7 (56/44)
Age at seizure onset (n)
0 – 3 months 7 13
4 – 12 months 1 2
>12 months 0 1
Patients with ASM use at baseline
1 or 2 ASM 2 4
3 or 4 ASM 5 11
Baseline motor seizures per 28-day, median (min, max) 58.7 (15, 844) 53.5 (13, 844)
Baseline log-transformed motor seizures per 28-day, mean (SE) 4 (0.4) 3.3 (0.3)
Baseline CGI-S, mean (min, max) 5.5 (4, 6) 5.6 (4, 6) |
| 16
Relutrigine was generally well-tolerated
*Infections include bronchiolitis, conjunctivitis, gastroenteritis, influenza, metapneumovirus infection, nasopharyngitis, otitis media, pneumonia, respiratory tract
infection, rhinovirus infection scarlet fever, tonsillitis, upper respiratory tract infection
Placebo
(n=8)
Total
(n=16)
Any TEAE 4 (50%) 14 (88%)
TEAEs > 2 patients
Infections* 3 (38%) 8 (50%)
Vomiting 1 (13%) 5 (31%)
Pyrexia 0 5 (31%)
Somnolence 0 4 (25%)
Constipation 0 3 (19%)
Nasopharyngitis 2 (25%) 1 (6%)
AEs were
mostly mild to
moderate
No drug-related
SAE
No dose
reduction of
relutrigine
required
One severe TEAE of status epilepticus related to an infection |
| 17
Relutrigine demonstrated robust reduction in motor seizures and unprecedented
seizure-free status per 28-day period
*Percent reduction derived from log-transformed placebo-adjusted relutrigine effect
**Assessment of motor seizures over the controlled plus open-label periods through August 21, 2024
• 33% of patients seizure-free after initiating on
relutrigine**
• Longest follow-up >200
days seizure-free
5 patients
1,778 Motor Seizures at Baseline
(n=15)
46%
placebo-adjusted reduction
in motor seizures over
double-blind period*
Seizure Freedom Periods Never
Seen Before in this Population |
| 18
-90%
-80%
-70%
-60%
-50%
-40%
-30%
-20%
-10%
0%
Relutrigine patients demonstrated significant improvement over the short and
long-term in motor seizures
Long-term extension data for 8 patients with data available for at least one 28-day period as of August 21, 2024
Placebo (n=7)
-1.6%
Relutrigine (n=8)
-27%
Relutrigine (n=8)
-75%
7 patients increased
the dose of
relutrigine to 1 mg/kg
during the double-blind period,
2 additional patients
during the long-term
extension
Seizure freedom
associated with
exposures achievable
by 1 mg/kg
Single 28-day period Long-term extension
Median Improvement |
| Clinical Global Impression of Improvement and Caregiver Global Impression of Improvement assessed at Week-16 visit 19
57%
71%
43%
29%
69%
62%
31%
23%
0% 10% 20% 30% 40% 50% 60% 70% 80%
Alertness
Seizure Severity and Intensity
Communication
Disruptive Behavior
Clinician Caregiver
Relutrigine treatment led to disease modifying impact
Meaningful gains in overall well-being of patients, despite severity and
historical lack of improvement with available treatments
% of patients showing improvement in the CGI-I and CgGI-I domains |
| 20
Next Steps
RELUTRIGINE |
| 21
Relutrigine - EMBOLD delivers unparalleled results in DEE
46% placebo-adjusted seizure
reduction
Unprecedented level of
seizure freedom
5 patients seizure-free for
longer than 28 days
Well-tolerated in a
heavily treated
population
75% long-term
median seizure
reduction
Disease
modifying impact
for patients
assessed by
clinicians and
caregivers
Initiated an
expanded
registration
cohort |
| 22
SCN2A and SCN8A are the tip of the iceberg to address significant unmet need
for other DEEs
*Based PubMed Search of DEEs that could use SCBs to treat focal seizures when they presented.
>$500m peak
revenue
Low tolerability and
inadequate response
>70%
DEE patients treated with
sodium channel blockers*
SCN2A, SCN8A
Other DEEs
High Seizure Burden
+
Genetic Epilepsies >$2bn peak
revenue market
opportunity
>100,000
patients
~5,000
patients |
| 23
Regulatory agency
input
• EMBOLD registrational Cohort 2 initiated
• Leveraging EMBOLD successful study design
Next steps
Initiated registrational trial for SCN2A and 8A, discuss Other DEEs with FDA by Q1 2025
2H 2024 1H 2025
Initiate EMERALD Trial
1:1
Randomization
N=80
(SCN2A/SCN8A)
Relutrigine for 4 x 4 weeks
1 mg/kg/day
Placebo for 1 x 4 weeks
Relutrigine for 3 x 4 weeks
1 mg/kg/day
SCN2A
/8A
DEES DEEs
Relutrigine
Placebo
Ongoing Study
Preliminary Design |
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