Solvonis TherapeuticsLSE: SVNS
Also known as: Graft Polymer (UK) PLC, Awakn Life Sciences Corp
Solvonis Therapeutics plc (LSE: SVNS) is a London-listed, clinical-stage biopharmaceutical company developing evidence-based treatments for addiction and mental health disorders. Formed through the rebranding of Graft Polymer (UK) PLC and the acquisition of Awakn Life Sciences Corp (NEO: AWKN, completed May 2025), Solvonis inherited Awakn's lead programme SVN-001 — IV ketamine combined with manualised CBT — now in Phase 3 for severe alcohol use disorder, co-funded by the UK NIHR. The company also advances SVN-002 (buccal/sublingual esketamine for US AUD) and SVN-SDN-14 (novel SDN receptor modulators for PTSD at preclinical stage), plus an AI-driven CNS discovery engine.
Development Programmes
4SVN-001 (IV Ketamine + CBT)
EsketamineSevere alcohol use disorder
Programme Tracker
Alcohol Use Disorder (AUD)
More-KARE Phase 3 recruiting at 8 NHS Trusts UK (ISRCTN85955128); n=280; co-funded by NIHR (£2.4M) and Solvonis; results expected late 2026/early 2027
Milestones
Phase II topline
CompletedActual: Jan 1, 2021
KARE Phase 2 (UCL): 86% abstinence at 6 months in ketamine+therapy arm vs 2% pre-trial; 50% reduction in heavy drinking days vs placebo
Why it matters: The KARE Phase 2 produced one of the largest effect sizes ever reported in AUD treatment. 86% abstinence at 6 months far exceeds standard-of-care naltrexone or acamprosate. The key mechanism combines ketamine's memory reconsolidation blocking with behavioural therapy targeting reward memories.
Phase III started
CompletedActual: Jul 1, 2024
More-KARE Phase 3 recruitment began at 8 NHS Trusts (ISRCTN85955128, n=280)
Why it matters: More-KARE is the largest ever randomised trial of ketamine-assisted therapy for AUD. NIHR co-funding alongside Solvonis reduces financial risk and gives the trial the highest NHS/academic credibility. Results expected late 2026/early 2027.
Watch next: More-KARE Phase 3 top-line results
Recorded Events
Jul 1, 2024: Phase III started
Jan 1, 2021: Phase II topline
SVN-002 (Esketamine Oral Thin Film)
EsketamineAlcohol use disorder (US market)
Programme Tracker
Alcohol Use Disorder (AUD)
Translational bridging studies initiated July 2025; pre-IND FDA meeting (Dec 2024) supportive of 505(b)(2); Phase 2b planning underway
Milestones
Pre-clinical completed
CompletedActual: Jul 22, 2025
Translational bridging studies initiated (July 22, 2025)
Why it matters: Bridging studies establish PK/PD equivalence between SVN-002 OTF and Spravato — required for the 505(b)(2) submission. Successful bridging would allow Phase 2b to begin without a full Phase 1.
Watch next: Bridging study results and IND filing for Phase 2b
Regulatory review accepted
CompletedActual: Dec 1, 2024
Pre-IND meeting with FDA: FDA supportive of 505(b)(2) pathway referencing Spravato (esketamine nasal spray) safety data
Why it matters: SVN-002 is a sublingual/buccal esketamine oral thin film (OTF) formulated with psychosocial support protocols. 505(b)(2) referencing Spravato dramatically reduces the safety data burden for IND and NDA filing. Oral thin film delivery enables home use without nasal spray administration — expanding the addressable AUD patient population.
Recorded Events
Jul 22, 2025: Pre-clinical completed
Dec 1, 2024: Regulatory review accepted
SVN-SDN-14
Post-traumatic stress disorder
Programme Tracker
PTSD
Preclinical development of serotonin/dopamine/noradrenaline (SDN) modulator series for PTSD
Milestones
Pre-clinical completed
In progressWhy it matters: SVN-SDN-14 is a series of SDN receptor modulators designed to promote pro-social behaviour for PTSD therapy. The design explicitly aims to improve on MDMA's safety profile — positioning it as a cleaner entactogen without MDMA's cardiovascular or neurotoxicity concerns.
Watch next: Lead compound selection and IND-enabling timeline
SVN-015
Methamphetamine and cocaine use disorder (stimulant addiction)
Programme Tracker
Substance Use Disorders (SUD)
Accepted into NIDA Addiction Treatment Discovery Program (late 2025); NIDA funding covers cardio-risk and preclinical efficacy studies (est. £3–5M non-dilutive); early results expected 2026
Milestones
Funding milestone
CompletedActual: Dec 1, 2025
SVN-015 accepted into NIDA Addiction Treatment Discovery Program for methamphetamine and cocaine addiction
Why it matters: There are no FDA-approved medications for methamphetamine or cocaine use disorder — the largest unmet need in addiction medicine. NIDA program acceptance provides non-dilutive preclinical funding and regulatory pathway guidance, validating SVN-015's scientific premise. The programme was discovered via Solvonis's AI-driven drug discovery platform.
Watch next: Preclinical efficacy and cardio-safety results from NIDA programme (2026); IND-enabling timeline
Recorded Events
Dec 1, 2025: Funding milestone
Quick Facts
- Type
- Public Biotech
- Founded
- 2020
- Ticker
- LSE: SVNS
- Lead Stage
- Phase III
- HQ
- Eccleston Yards, 25 Eccleston Place, London SW1W 9NF, UK, United Kingdom
- Website
- Visit