Awakn Life Sciences (CSE:AWKN; OTCQB:AWKNF; FSE:954) has announced that the first patient has been screened in its landmark MORE-KARE Phase 3 trial of AWKN-001, an investigational, novel medication-assisted treatment for severe alcohol use disorder (AUD).
AWKN-001 consists of an N-methyl-D-aspartate receptor-modulating drug, ketamine, delivered intravenously in combination with manualized psycho-social support, available exclusively in the UK market.
The MORE-KARE study is co-funded through a partnership between Awakn, the UK’s Medical Research Council, and the National Institute for Health and Care Research, and is managed by the Exeter Clinical Trials Unit. The primary endpoint is the reduction in heavy drinking days over a six-month period post-treatment. Secondary endpoints include continuous abstinence and the percentage of heavy drinking days at the six-month follow-up.
In a statement, Prof. David Nutt, Psy.D., chief research officer of Awakn, said, “This trial could potentially revolutionize the treatment landscape for severe AUD, offering hope to those who currently have limited options. We’re excited to see the impact of combining ketamine with structured psychological support.”
AUD is a chronic, relapsing brain health disorder characterized by compulsive alcohol use, loss of control over drinking, and negative emotional states when not using alcohol. In 2019, approximately 400 million people aged 15 and older lived with AUD, according to the World Health Organization.
