The research partnership between UK-based psychedelics biotech Awakn Life Sciences Corp. (OTCQB: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.
Benzinga’s PCC 2023
Missed our Psychedelics Capital Conference? Here’s some EXCLUSIVE coverage from the event’s second edition:
-
Investing In The Unique Growth Market Of Psychedelics
-
Infrastructure Built For Healing: ‘Consolidation And Legitimacy Are Crucial For Psychedelic Industry Growth’
-
Ketamine Therapy Leaders Share Bold Vision For Future At Benzinga’s Psychedelics Capital Conference
-
In Reinventing Mental Health & Next-Gen Psychedelics, ‘Access And Clinical Data Are Key’
-
Making The World A Better Place, How Psychedelics Are Helping
Photo: Benzinga edit with photo by Kunlanan Yarist and luchschenF on Shutterstock.
