REG - Solvonis Therapeutic - Update on Awakn Life Sciences’ R&D Progress

Solvonis TherapeuticsAnnouncement

27/01/2025 07:00

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RNS Number : 6694U  Solvonis Therapeutics PLC  27 January 2025

27 January 2025

 

Solvonis Therapeutics plc

("Solvonis" or the "Company")

Update on Awakn Life Sciences' Research and Development Progress

 

Solvonis Therapeutics plc (LSE: SVNS), an innovative biotechnology company
co-developing therapeutics for mental health disorders, provides the following
overview and update on the research and development ("R&D") progress of
Awakn Life Sciences Corp. ("Awakn"), the company that Solvonis plans to
acquire.  Details of the Company's proposed acquisition of Awakn were set out
in its announcement on 16 December 2024.

 

Awakn currently has three principal R&D programmes, as outlined below:

 

 

 

1. AWKN-001: Combination therapy for severe alcohol use disorder ("AUD")

 

AWKN-001 is an investigational, novel combination therapy consisting of an
N-methyl-D-aspartate ("NMDA") receptor-modulating drug (ketamine) delivered
intravenously ("IV") in combination with copywritten relapse prevention
cognitive behavioural therapy ("CBT") for the treatment of severe AUD in the
UK and potentially the EU.

 

Phase 2 results demonstrated a 50% reduction in heavy drinking days in the 6
months post treatment versus the placebo. The phase 2 results also
demonstrated an on average 86% abstinence rate in the 6 months post treatment
versus 2% abstinence pre-trial.

 

Current status: AWKN-001 is in a Phase 3 clinical trial in the UK across 9 NHS
Trusts. The Phase 3 trial is co-funded by a partnership between the UK's
Medical Research Council (the "MRC"), the National Institute for Health and
Care Research (the "NIHR"), and Awakn. Awakn's costs are capped at £800,000.
The trial is managed the University of Exeter Clinical Trials Unit.

 

Regulatory path and exclusivity: Awakn is targeting a Regulation 52b hybrid
application in the UK for AWKN-001. If successful, this could provide 8 years
of market exclusivity, with an additional 2 years of supplementary protection,
preventing competitors from marketing a similar product for the same
indication. Awakn is planning to commence market access discussions with the
UK Department of Health this year.

 

2. AWKN-002: Esketamine oral thin film ("OTF") for AUD

 

AWKN-002 is a proprietary oral thin film ("OTF") formulation of esketamine,
developed for sublingual and buccal administration in combination with
structured alcohol education for moderate to severe AUD in the US.

 

Current status: Awakn has in-licensed a Phase 1 programme from LTS Lohmann
Therapie-Systeme AG and has completed two mechanistic studies in AUD with
AWKN-002. The data from these studies was used to file method-of-use patents.
Awakn also held a pre-Investigational New Drug ("IND") meeting with the US
Food and Drug Administration (the "FDA") in December 2024, where the FDA
confirmed that AWKN-002 can be reviewed under the 505(b)(2) New Drug
Application ("NDA") pathway. Furthermore, the FDA confirmed that no additional
clinical data is required to proceed with a Phase 2b trial in patients with
moderate to severe AUD.

 

Patents have been filed for esketamine OTF formulation and esketamine OTF AUD
method of use.

 

Regulatory path and exclusivity:  Awakn plans to submit an IND Application
for AWKN-002 in H2 2025, followed by a Clinical Trial Application ("CTA") for
a Phase 2b trial in H1 2026. In due course, Awakn will submit a NDA under the
505(b)(2) pathway. The reference product for Awakn's NDA will be J&J's
Spravato®, which is forecast to achieve US$1bn in sales in 2024. Subject to
successful clinical trial outcomes and FDA approval, AWKN-002 could be granted
up to 5 years of market exclusivity in the US for the treatment of AUD,
provided its patents are granted and recognised in the US Orange Book. Awakn
anticipates that the Phase 2b clinical trial application will be made in 2026.

 

3. AWKN-SND-14: Pre-clinical investigation for Post-Traumatic Stress Disorder
("PTSD")

 

AWKN-SND-14 is a series of serotonin, dopamine, and noradrenaline modulators
under pre-clinical investigation for trauma-related mental health disorders,
including PTSD. Previously, this programme was referred to as Awakn's
aminoindane new chemical entity programme.

 

Programme focus: AWKN-SND-14 is designed to promote pro-social behaviour with
a potentially improved safety profile compared to existing investigational
treatments for PTSD. By enhancing trust, empathy, and social bonding, critical
elements in addressing PTSD, AWKN-SND-14 aims to help individuals rebuild
relationships, overcome isolation, and engage more effectively in therapy.

 

Awakn anticipates identifying a lead candidate and initiating lead
optimisation in 2025, with pre-clinical development work commencing in 2026
and IND enabling studies taking place in 2028 ahead of IND submission in 2029.

 

Awakn's approach to treating addiction

 

Awakn's therapeutics for addiction target the brain circuits that drive
addiction. These circuits control the behavioural drivers of addiction, as set
out in the image below. This disruption allows the individual to escape from
the repetitive addictive behaviours and thoughts, and in doing so engage with
a psychotherapeutic process to enable lasting positive change.

 

 

Awakn's approach using proprietary therapeutics, disrupts the circuits and the
deep-rooted addictive behaviours with drugs and allows the therapy to
penetrate deeper and to restore the necessary control back into the cognitive
control centre, as set out in the image below.

 

 

Proposed acquisition of Awakn

 

Solvonis continues to evaluate the developments set out above as part of its
ongoing review process for the acquisition of Awakn. Further updates will be
provided as the acquisition progresses.

 

 

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 PTSD

PTSD is a debilitating mental health condition characterised by persistent and
distressing symptoms resulting from exposure to traumatic events. Individuals
with PTSD often experience intrusive memories, flashbacks, nightmares,
hypervigilance, and avoidance behaviours, leading to significant impairment in
daily functioning and overall well-being. Despite its prevalence, with an
estimated 13 million 4  (#_ftn4) adults in the US and with the Company
estimating a current affected population of 20 million in the US and key
European markets affected by PTSD, the condition remains underdiagnosed and
underserved. Current treatment options often fall short in providing adequate
relief, leaving many individuals without effective therapeutic solutions

 

 

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

 4  (#_ftnref4) VA National Center for PTSD. US Department of Veterans
Affairs.

 

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