TIDMDEST
Destiny Pharma PLC
16 October 2019
Destiny Pharma plc
("Destiny Pharma" or the "Company")
Positive results published from an independent (US National
Institute of Health) XF-73 phase 1 clinical trial in a peer
reviewed journal
The publication in the Journal of Global Antimicrobial
Resistance concluded that application of a nasal gel formulation of
XF-73 in healthy volunteers was safe, well tolerated and generated
minimal side effects
Treatment with XF-73 was also associated with a rapid reduction
in nasal Staphylococcus aureus in all subjects; nasal carriage of
the bacteria is the source of the majority of post-surgical
bacterial infections
The same nasal formulation is being used in the Company's phase
2b trial assessing the microbiological effect of XF-73 on nasal S.
aureus in patients scheduled for cardiac surgery and at high risk
of post-operative S.aureus/MRSA infection; headline results
continue to be expected in mid-2020
Brighton, United Kingdom - 16 October 2019 Destiny Pharma (AIM:
DEST), a clinical stage biotechnology company focused on the
development of novel antimicrobial drugs that address clear
commercial opportunities and also address the global problem of
antimicrobial resistance (AMR), notes the publication of results
from a positive phase 1 clinical study in 60 healthy US volunteers
using a nasal gel formulation of its lead drug, XF-73 (exeporfinium
chloride), in the peer reviewed Journal of Global Antimicrobial
Resistance [Yendewa GA, Griffiss JM, Jacobs MR et al; J. Glob.
Antimicrob. Resist. 2019 Oct 7. pii: S2213-7165(19)30250-4. doi:
10.1016/j.jgar.2019.09.017]. The headline results from this study
were previously announced by Destiny Pharma on 5 September
2016.
The reported US study was independently conducted and sponsored
by the National Institute of Allergy and Infectious Diseases, part
of the US National Institutes of Health (NIH). In addition to the
study reporting a favourable safety and local tolerability profile
of the nasal gel formulation (the primary objective), the study
also noted, as expected, that exposure to XF-73 produced a rapid
reduction in levels of nasal S. aureus in all subjects.
Destiny Pharma is initially developing a nasal gel formulation
of XF-73 as a novel therapy to prevent post-surgical infection,
including those from methicillin resistant S. aureus (MRSA), as
nasal carriage is the source of >80% of S.aureus/MRSA
post-surgical bacterial infections. The Company is currently
conducting a 200 patient multi-centre, randomised, blinded,
placebo-controlled phase 2b study of a single concentration of
XF-73 nasal gel. This is to assess the anti-staphylococcal effect
of XF-73 on S. aureus nasal carriage in US and European patients
scheduled for cardiac surgical procedures deemed to be at high risk
of post-operative S. aureus infection. Headline results from the
trial are anticipated in mid-2020.
Neil Clark, CEO of Destiny Pharma, commented:
"The full results from this positive phase 1 clinical study,
independently conducted and sponsored by the NIH, underscores our
confidence in the potential of XF-73 as a novel treatment to
prevent the occurrence of post-surgical S. aureus bacterial
infections which is a significant commercial opportunity.
Importantly, there is no evidence to date suggesting that XF-73
causes bacterial resistance which is in contrast to current
preventative treatments such as the application of the antibiotic
mupirocin, which the use of is increasingly blunted by the rising
incidence of resistant strains of S. aureus. We look forward to
reporting headline data in mid-2020 from our ongoing 200 patient
phase 2b trial that is assessing the ability of XF-73 to reduce
nasal levels of S. aureus in patients at high risk of infection
that are undergoing surgery."
Abstract in full
Yendewa GA, Griffiss JM, Jacobs MR etc al; J. Glob. Antimicrob.
Resist. 2019 Oct 7. pii: S2213-7165(19)30250-4. doi:
10.1016/j.jgar.2019.09.017
OBJECTIVES:
There is conflicting data on the success of mupirocin as an
effective decolonizing regimen for Staphylococcus aureus (SA)
carriage, in part due to increasing drug resistance. This
multi-center, randomized, open-label, prospective phase 1 study
compared the safety and local tolerability of two nasal
formulations of XF-73, a novel porphyrinic antibacterial drug with
rapid intrinsic activity against SA.
METHODS:
The study was conducted in 2 dosing cohorts and enrolled 60
healthy adults. In Part 1, 8 non-SA carriers were randomized to 2
groups of 4 subjects in each arm and were treated with the new
formulations of XF-73 in concentrations of 0.5 mg/g 2% gel and 2
mg/g 2% gel, respectively. In Part 2, 52 healthy persistent SA
carriers were randomized to 4 groups of 13 subjects in each arm and
were treated with three different concentrations of XF-73 (0.5 mg/g
2% gel, 2 mg/g 2% gel and 0.5 mg/g 4% gel) or a 4% viscosified
placebo gel, respectively. Plasma pharmacokinetics (PK) and
pharmacodynamics (PD) studies were performed. Anti-staphylococcal
activity was assessed as the presence or absence of SA and by
quantification of the level of colonization using a
semi-quantitative scale (SA score).
RESULTS:
56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed
the study, with 47/60 comprising the PK population and 48/60 the PD
population. There was no measurable systemic absorption of XF-73
from nasal application. Treatment with XF-73 was associated with a
rapid diminution in the SA scores in all subjects. The most common
treatment emergent adverse events (TEAE) reported were rhinorrhea
and nasal dryness (15.5% each in Part 1 and Part 2). TEAEs were
mostly mild and resolved spontaneously.
CONCLUSION:
XF-73 was found to be safe and was tolerated with minimal side
effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy
volunteers. These findings support moving on to Phase 2 trials to
further evaluate the efficacy of XF-73.
For further information, please contact:
Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
pressoffice@destinypharma.com
+44 (0)1273 704 440
FTI Consulting
Simon Conway / Victoria Foster Mitchell
destinypharma@fticonsulting.com
+44 (0) 20 3727 1000
finnCap Ltd (Nominated Adviser and Joint Broker)
Geoff Nash /Anthony Adams, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500
WG Partners (Joint Broker)
Nigel Barnes / Claes Spång / Nigel Birks
+44 (0)20 3705 9321
About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative
biotechnology company focused on the development and
commercialisation of novel medicines from its XF Platform that
represent a new approach to the treatment of infectious disease.
The company's lead programme is undergoing a Phase 2b clinical
trial and is targeting the prevention of post-surgical hospital
infections including MRSA. The XF drug candidates are being
developed for the prevention and treatment of life-threatening
infections caused by antibiotic--resistant bacteria, often referred
to as "superbugs". Tackling anti-microbial resistance has become a
global imperative recognised by the World Health Organisation (WHO)
and the United Nations, as well as the G7 and the G20 countries.
For further information, please visit
https://www.destinypharma.com
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END
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