1 domain / 2 areas / 1 specialization
Awakn Life SciencesCSE: AWKN
Data updated
Awakn Life Sciences is a former UK-based biopharmaceutical company whose ketamine and esketamine alcohol-use-disorder assets were acquired by Solvonis Therapeutics in May 2025. Its lead programmes are now represented operationally by Solvonis as SVN-001 (IV ketamine plus CBT for severe AUD) and SVN-002 (esketamine oral thin film for US AUD). This record is retained for historical provenance of the Awakn-origin assets and source trail.
Development Programmes
2AWKN-001
KetamineHistorical Awakn-origin record for AWKN-001, the KARE ketamine-assisted relapse-prevention protocol for alcohol use disorder. Following Solvonis Therapeutics acquisition of Awakn in May 2025, current operational development is tracked under Solvonis as SVN-001.
Programme Tracker
Alcohol Use Disorder (AUD)
Forecast
Phase III topline - Approval eventual: 40%
Historical Awakn record. MORE-KARE Phase 3 is now tracked under Solvonis Therapeutics as SVN-001 following completion of the Awakn acquisition in May 2025.
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 - Oct 5, 2021 - Verified
Publication - American Journal of Psychiatry - Jan 11, 2022 - Verified
AWKN-002
EsketamineHistorical Awakn-origin record for AWKN-002, now represented by Solvonis as SVN-002: an esketamine oral thin-film programme for moderate-to-severe AUD in the US via a planned 505(b)(2) pathway.
Programme Tracker
Alcohol Use Disorder (AUD)
Forecast
Phase II started - Likely: Q4 2026
Historical Awakn/SVN-002 record. Current development, including the June 2026 bridging-data update and planned US Phase 2b/IND pathway, is tracked under Solvonis SVN-002.
Milestones
Phase II planned
CompletedActual: Dec 18, 2024
Awakn announced positive FDA pre-IND feedback for AWKN-002 in AUD, including no additional clinical data before Phase 2b and agreement on a 505(b)(2) pathway.
Why it matters: This moves AWKN-002 from a discovery listing to a defined U.S. Phase 2b-planning regulatory path.
Watch next: IND filing, scientific bridge to Spravato, or Phase 2b clinical trial authorization/registration.
Phase II planned
In progressActual: Apr 28, 2026
Solvonis renamed/integrated AWKN-002 as SVN-002 and reported it progressed in Phase 2 planning for moderate-to-severe AUD in the U.S.
Why it matters: Confirms the asset remained active after the Awakn acquisition and is part of Solvonis current AUD strategy.
Watch next: U.S. IND or CTA update for the Phase 2b study.
Recorded Events
Apr 28, 2026: Phase II planned
Dec 18, 2024: Phase II planned
Evidence Links
Press release - Newsfile / Awakn Life Sciences - Dec 18, 2024 - Verified
FDA confirmed no additional clinical data are required before Phase 2b and agreed AWKN-002 can use the 505(b)(2) pathway once a bridge to the reference esketamine product is established.
Press release - Solvonis Therapeutics - May 27, 2025 - Verified
Solvonis describes SVN-002 as a Phase 2b-planning sublingual/buccal esketamine programme for moderate-to-severe AUD in the US.
Press release - Solvonis Therapeutics - Apr 28, 2026 - Verified
FY2025 results state SVN-002, previously AWKN-002, progressed in Phase 2 planning for moderate-to-severe AUD in the U.S. and is advanced via a planned 505(b)(2) pathway.
Quick Facts
- Type
- Public Biotech
- Founded
- 2020
- Ticker
- CSE: AWKN
- Lead Stage
- Phase III
- Acquired by
- Solvonis Therapeutics
- Website
- Visit