THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES
OF ARTICLE 7 OF EU REGULATION 596/2014 AS IT FORMS PART OF DOMESTIC
LAW IN THE UNITED KINGDOM BY VIRTUE OF THE EUROPEAN UNION
(WITHDRAWAL) ACT 2018. UPON THE PUBLICATION OF THIS ANNOUNCEMENT
VIA A REGULATORY INFORMATION SERVICE, THIS INSIDE INFORMATION WILL
BE CONSIDERED TO BE IN THE PUBLIC DOMAIN.
21
January 2025
Solvonis Therapeutics
plc
("Solvonis" or the
"Company")
Update on FDA Pre-IND Meeting
for Awakn Life Sciences' Drug Candidate AWKN-002
· FDA
supports AWKN-002's progression to Phase 2b clinical trial without
requirement for additional clinical data
· FDA
endorses use of 505(b)(2) NDA pathway, enabling a streamlined
regulatory process and potential for faster market
access
· AWKN-002 is being developed for the treatment of alcohol use
disorder in the U.S.
Solvonis Therapeutics plc (LON:
SVNS), ("Solvonis" or the "Company") an innovative biotechnology
company co-developing therapeutics for mental health disorders, is
pleased to announce that Awakn Life Sciences Corp. ("Awakn"), the
company Solvonis plans to acquire, has reached a significant
regulatory milestone. Awakn announced a positive outcome from a
Pre-Investigational New Drug ("Pre-IND") meeting with the U.S. Food
and Drug Administration ("FDA") regarding AWKN-002, a proprietary
oral thin film ("OTF") formulation of esketamine, designed for
sublingual and buccal administration in combination with structured
alcohol education. This drug candidate is being developed for the
treatment of moderate to severe alcohol use disorder ("AUD") with a
focus on U.S market.
The Pre-IND meeting, held on 16
December 2024, marks a critical step in the U.S. drug development
process. During the meeting, Awakn received positive feedback from
the FDA regarding its development strategy for AWKN-002. Notably,
the FDA confirmed that no additional clinical data are required
prior to initiating a Phase 2b trial for AWKN-002 in patients with
moderate to severe AUD enabling Awakn to expedite its clinical
development program. This decision provides a clear path forward
for advancing the drug to the next phase of clinical
testing.
Additionally, the FDA agreed that
AWKN-002 can be reviewed under the 505(b)(2) New Drug Application
(NDA) approval pathway. This pathway allows data from an approved
esketamine product to support the development of AWKN-002 for AUD
treatment, provided a scientific bridge is established between
AWKN-002 and the reference product. This regulatory pathway is
expected to streamline the process and potentially reduce time to
market.
This outcome represents a major
milestone for Awakn and, by extension, for Solvonis, highlighting
AWKN-002's potential as a breakthrough treatment for AUD, a
condition with significant unmet medical need. The positive
feedback from the FDA reinforces the scientific and clinical
promise of AWKN-002, enhancing its value as Solvonis continues with
its proposed acquisition of Awakn, as announced on 16 December
2024.
Anthony Tennyson, Chief Executive Officer of
Solvonis, commented: "We are very
pleased with the successful outcome of Awakn's Pre-IND meeting with
the FDA. The FDA's support for Awakn's development strategy,
particularly their confirmation that AWKN-002 can proceed to Phase
2b once a suitable scientific bridge to the product has been
established. This marks a significant milestone for Awakn and by
extension Solvonis."
Prof. David Nutt, Senior Scientific Advisor of
Solvonis, commented: "The outcome of
Awakn's Pre-IND meeting with the FDA is a significant advancement
for AWKN-002 as a potential treatment for AUD. The FDA's support
for the 505(b)(2) pathway is a valuable endorsement of the
scientific approach behind AWKN-002. This progress is a promising
development not only for Awakn but also for Solvonis as we continue
to develop transformative solutions for substance use
disorders."
Further updates will be provided as
the regulatory process progresses and additional clinical
milestones are achieved.
Enquiries:
Solvonis Therapeutics plc
Anthony Tennyson, CEO and Executive Director.
anthony@solvonis.com
Allenby Capital (Financial Adviser and Broker)
+44 (0) 20 3328 5656
Nick Naylor
/ Liz Kirchner (Corporate Finance) | Guy McDougall
(Sales)
About AUD
AUD is a chronic, relapsing brain
health disorder characterised by compulsive alcohol use, loss of
control over drinking, and negative emotional states when not using
alcohol. It affects individuals across diverse demographics and can
lead to a wide range of physical, psychological, and social
consequences. AUD affects approximately 29 million[1] adults in the U.S. with Awakn estimating a
current affected population of 40 million in the US and UK and key
European markets. Despite this high prevalence treatment success
rates are very low with up to 75% of patients with AUD returning to
harmful drinking within 12 months of treatment[2]. This high prevalence rate and low treatment
success rate creates a significant unmet medical need, a
significant public health concern, and an enormous economic cost
$249 billion in the U.S[3].
About Solvonis Therapeutics plc
Solvonis Therapeutics plc is an
innovative biotechnology company focused on developing intellectual
property related to the treatment of mental health and substance
use disorders, and co-developing therapeutics for mental health
disorders. Solvonis' mission is to improve outcomes for individuals
suffering from mental health disorders, with an initial focus on
trauma-related mental health conditions, such as PTSD. PTSD
affected approximately 13 million adults in the U.S. in 2020, with
the Company estimating a current affected population of 20 million
across the U.S., UK, and key EU markets.
www.solvonis.com
| LinkedIn
| X (formerly
Twitter)
About Awakn Life Sciences Corp.
Awakn Life Sciences Corp. is a
clinical-stage biotechnology company developing therapeutics
targeting substance use and mental health disorders. Awakn has a
near-term focus on AUD, a condition affecting approximately 29 million adults in the US with Awakn
estimating a current affected population of 40 million in the US
and US and key European markets for which
the current standard of care is inadequate. Awakn's goal is to
provide breakthrough therapeutics to addiction sufferers in
desperate need and its strategy is focused on commercialising its
R&D pipeline across multiple channels.
www.awaknlifesciences.com |
LinkedIn |
X (formerly
Twitter)