Solvonis Therapeutics PLC (LSE:SVNS) has updated investors on the research and development (R&D) advancements at Awakn Life Sciences Corp, the biotechnology it intends to acquire.
Awakn is advancing three programmes focused on addressing mental health and addiction disorders.
The first program, AWKN-001, combines intravenous ketamine with cognitive behavioural therapy (CBT) to treat severe alcohol use disorder (AUD).
Results from Phase 2 trials revealed a 50% reduction in heavy drinking days and an average abstinence rate of 86% over six months post-treatment, compared to 2% before the trial.
Phase 3 trials are currently underway at nine NHS Trusts in the UK, with costs capped at £800,000.
Meanwhile, the second project, for AWKN-002, involves a proprietary esketamine oral thin film (OTF) designed for moderate-to-severe AUD.
After a pre-Investigational New Drug meeting with the FDA in December 2024, Awakn recently received clearance to proceed to Phase 2b trials without the need for additional clinical data.
An IND (investigational new drug) application is planned for the second half of 2025, followed by a clinical trial application in early 2026.
Separately, the AWKN-SND-14 programme is focused on pre-clinical investigation of serotonin, dopamine, and noradrenaline modulators for post-traumatic stress disorder (PTSD).
Lead candidate selection is expected in 2025, with pre-clinical development scheduled to begin the following year.
Solvonis is evaluating these developments as part of its ongoing review process for the proposed acquisition of Awakn.