Awakn Announces Phase 3 Clinical Trial for AWKN-001 in Severe Alcohol Use Disorder
Phase 3 Clinical Trial Underway
According to a recent press release, Awakn Life Sciences Corp. (Awakn), a clinical-stage biotechnology company dedicated to developing and delivering psychedelic medicines for the treatment of addiction and mental health conditions, announced that it has screened the first patient in its Phase 3 clinical trial of AWKN-001 for severe alcohol use disorder (AUD).
Landmark Trial
The Phase 3 clinical trial, known as MORE-KARE, is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of AWKN-001, a ketamine-assisted therapy, in reducing alcohol consumption and improving overall outcomes in individuals with AUD.
The trial will enroll approximately 200 participants across multiple sites in the United Kingdom. Participants will receive either AWKN-001 or a placebo in addition to standard medical care. The primary outcome measure will be the percentage of heavy drinking days at week 24.
Promising Results
AWKN-001 has shown promising results in previous clinical trials. In a Phase 2a trial, AWKN-001 was found to be safe and well-tolerated, and it demonstrated significant efficacy in reducing alcohol consumption and improving other measures of AUD severity.
The Phase 3 trial is expected to provide further evidence of the efficacy and safety of AWKN-001 for the treatment of AUD. If successful, the results of the trial could lead to the approval of AWKN-001 as a new treatment option for individuals with AUD.
About Awakn Life Sciences
Awakn Life Sciences is a clinical-stage biotechnology company dedicated to developing and delivering psychedelic medicines for the treatment of addiction and mental health conditions. The company's mission is to improve the lives of patients by providing access to safe, effective, and innovative treatments.
For more information, please visit the Awakn Life Sciences website: https://awaknlifesciences.com/
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