Awakn Life SciencesCSE: AWKN
UK-based biopharmaceutical company developing ketamine and esketamine-based treatments for alcohol use disorder and addiction. AWKN-001 (IV ketamine combined with cognitive behavioural therapy) is in Phase 3 clinical trials in the UK for alcohol use disorder. AWKN-002, an esketamine oral thin film formulation, is in pre-IND development for the US market.
Development Programmes
2AWKN-001
KetamineAWKN-001 is the KARE (Ketamine-Assisted Relapse Prevention) therapeutic protocol — IV ketamine (0.8 mg/kg over ~40 min, multiple infusions) combined with structured manualized psychological therapy for alcohol relapse prevention. Licensed exclusively from the University of Exeter. Phase 2 KARE (NCT02649231, n=96): 86% abstinence rate over 6 months post-treatment; published American Journal of Psychiatry (2022). Phase 3 MORE-KARE (ISRCTN85955128): first patient screened August 2024 across 7-8 NHS UK sites — the largest ever trial of ketamine-assisted therapy for AUD. Pending acquisition by Solvonis Therapeutics (arrangement agreement February 2025).
Programme Tracker
Alcohol Use Disorder (AUD)
Forecast
Phase III topline - Approval eventual: 40%
MORE-KARE Phase 3 (ISRCTN85955128) actively enrolling across 7-8 NHS sites in England. MRC/NIHR co-funded (~£2.4M). Trial will generate UK regulatory-quality data. Awaiting Solvonis acquisition completion.
Milestones
Phase II topline
CompletedActual: Jan 11, 2022
Phase 2 KARE (NCT02649231, n=96) positive results published in American Journal of Psychiatry: ketamine + KARE achieved 86% abstinence over 6 months; relapse risk 2.7x lower than control
Why it matters: Landmark result for ketamine-assisted therapy in AUD; validated the KARE protocol and enabled Phase 3 MRC/NIHR co-funding
Watch next: Phase 3 MORE-KARE enrolment and topline data
Phase III started
CompletedActual: Aug 1, 2024
MORE-KARE Phase 3 (ISRCTN85955128) opened for enrolment; first patient screened at UK NHS sites. Co-funded by MRC and NIHR (~£2.4M).
Why it matters: First Phase 3 trial of ketamine-assisted therapy for AUD; UK government co-funding validates the scientific and clinical rationale
Watch next: Enrolment completion and topline data
Regulatory review accepted
CompletedActual: Oct 22, 2024
Four additional NHS sites opened in MORE-KARE (South London and Maudsley, Greater Manchester Mental Health, University Hospitals Sussex, Plymouth), bringing total to 7-8 active NHS sites
Why it matters: Multi-site enrolment across NHS builds an evidence base that directly supports NICE/MHRA approval and NHS commissioning decisions
Watch next: Solvonis acquisition completion; trial enrolment milestones
Company milestone
CompletedActual: Feb 22, 2025
Awakn entered arrangement agreement for acquisition by Solvonis Therapeutics plc (formerly Graft Polymer UK PLC); deal implies C$0.146/share (~53.5% premium). Combined entity would trade on London Stock Exchange.
Why it matters: Solvonis acquisition would provide capital and LSE listing to advance MORE-KARE; Solvonis also brings a Phase 3 pipeline (SVN-001)
Watch next: Acquisition completion, Solvonis LSE listing, MORE-KARE enrolment progress
Recorded Events
Feb 22, 2025: Company milestone
Oct 22, 2024: Regulatory review accepted
Aug 1, 2024: Phase III started
Jan 11, 2022: Phase II topline
Evidence Links
trial-registry - ClinicalTrials.gov - Verified
Publication - American Journal of Psychiatry - Jan 11, 2022 - Verified
AWKN-002
EsketamineEarly-stage discovery programme. No clinical development announced.
Quick Facts
- Type
- Public Biotech
- Founded
- 2020
- Ticker
- CSE: AWKN
- Lead Stage
- Phase III
- Website
- Visit