Awakn Life Sciences Advances Therapeutics for Substance Use and Mental Health Disorders

LOS ANGELES- Awakn Life Sciences Corp. a biotechnology company, has reported progress in its research and development programs targeting Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD).

AWKN-001: This investigational therapy combines intravenous ketamine with cognitive behavioral therapy (CBT) for severe AUD. Currently in a Phase 3 trial in the UK, co-funded by the UK’s Medical Research Council and the National Institute for Health and Care Research, Awakn’s financial commitment is capped at £800,000. The company aims for a Regulation 52b hybrid application in the UK, potentially granting up to 10 years of market exclusivity upon approval.

AWKN-002: This program involves a proprietary oral thin film formulation of esketamine, combined with structured alcohol education, targeting moderate to severe AUD in the U.S. Following a Pre-Investigational New Drug meeting, the U.S. Food and Drug Administration confirmed that AWKN-002 qualifies for the 505(b)(2) New Drug Application pathway, requiring no additional clinical data before initiating a Phase 2b trial. Awakn plans to submit an Investigational New Drug Application in the second half of 2025, with a Phase 2b trial application anticipated in the first half of 2026.

AWKN-SND-14: In pre-clinical development, this series of serotonin, dopamine, and noradrenaline modulators is being investigated for trauma-related mental health disorders, including PTSD. The compounds are designed to promote pro-social behavior and may offer an improved safety profile compared to existing treatments.

Awakn’s CEO, Anthony Tennyson, stated that the company is on track to deliver transformative therapies for patients in need of more effective solutions. Chief Research Officer Prof. David Nutt expressed optimism about AWKN-SND-14’s potential to offer a safer, more effective option for individuals suffering from trauma-related disorders.