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
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 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]
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
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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 |
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