Solvonis Therap Regulatory News (SVNS)

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 plcAnthony 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 | 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)