REG - Solvonis Therapeutic - Update on FDA Pre-IND Meeting for Awakn

Solvonis TherapeuticsAnnouncement

21/01/2025 07:00

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RNS Number : 0325U  Solvonis Therapeutics PLC  21 January 2025

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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
(mailto: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  (#_ftn1) 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  (#_ftn2) . 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  (#_ftn3) .

 

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 (http://www.solvonis.com) | LinkedIn
(http://www.linkedin.com/company/solvonis) | X (formerly Twitter)
(https://x.com/SolvonisTx)

 

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 (http://www.awaknlifesciences.com)  | LinkedIn
(http://www.linkedin.com/company/awakn-life-sciences)  | X (formerly Twitter)
(https://x.com/awakn_ls)

 

 1  (#_ftnref1) Substance Abuse and Mental Health Administration, 2022
National Survey on Drug Use and Health (NSDUH).

 2  (#_ftnref2) Treatment rates for alcohol use disorders: a systematic review
and meta-analysis, (Mekonen et al., 2021).

 3  (#_ftnref3) National Institute for Alcoholism and Alcohol Abuse (NIAAA),
Economic Burden of Alcohol Misuse in the United States

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