Severe Alcohol Use Disorder Patients Will Try Ketamine Therapy At Awakn's New Phase 3 Study

The research partnership between UK-based psychedelics biotech Awakn Life Sciences Corp. AWKNF and the University of Exeter for an upcoming Phase 3 clinical trial has now formalized the study’s design, budget and the company’s contribution of about $1 million (GBP £800,000).

The trial will assess ketamine-assisted therapy (KAT) for the treatment of severe Alcohol Use Disorder (AUD).

Awakn CEO Anthony Tennyson says the current formalization makes the years-long collaboration with UoE “even stronger” and gives “a clear roadmap” for Awakn’s Phase 3.

With the remaining costs being covered by the National Institute for Health and Care Research (NIHR), the Medical Research Council (MRC) and the university, the study will take place across ten UK National Health Service (NHS) sites and be conducted by Awakn head of KAT Celia Morgan. 

This randomized, placebo-controlled trial will be considerably large, recruiting a total of 280 participants, to be divided in two arms, and remains as the only Phase 3 goverment-funded psychedelic clinical trial to date. 

The study builds on the very positive results of a prior Phase 2 a/b trial targeting AUD, which showed an average 86% abstinence rate six months after treatment. 

Further, the company received an Innovation Passport designation as part of the Innovative Licensing and Access Pathway (ILAP) from U.K.'s regulatory body (MHRA), toward accelerating time-to-market. 

Should results from this Phase 3 study be positive, Awakn would then apply for marketing authorization for ketamine-assisted therapy to treat severe AUD.

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Photo: Benzinga edit with photo by Kunlanan Yarist and luchschenF on Shutterstock.