Pipeline
Therapeutic development pipeline
Program
Indication
Pre-clinical development
Phase I
Phase II A
Phase II B
Phase III
SVN-001
SVN-001 is a first-of-its-kind combination therapy combining IV ketamine (an NMDA receptor antagonist) with copyrighted manualised relapse prevention cognitive behavioural therapy, targeting both the biological and psychosocial aspects of alcohol use disorder.
Clinical evidence
Phase 2 results demonstrated a 50% reduction in Heavy Drinking Days vs a placebo.
Long-term impact: 86% abstinence on average sustained for six months post-treatment, compared to just 2% pre-trial.
Clinical development & regulatory pathway
SVN-001 is in phase 3, with an n=280 two-armed active placebo-controlled ‘More Kare’ trial. It is co-funded by the UK National Institute for Health Research Efficacy and Mechanism Evaluation Programme (NIHR150193) and Solvonis. It is being run by the University of Exeter Clinical Trials Unit.
Targeting a Regulation 52b hybrid application in the UK for approval as a new indication – to provide eight years of data exclusivity and two additional years of market protection.
SVN-002
Clinical evidence
Phase 1 was successfully completed by LTS Lohmann and in-licensed by Solvonis.
Clinical development & regulatory pathway
Now in Phase 2b planning, with a positive Pre-Investigational New Drug Application meeting with the US Food and Drug Administration (FDA) in December 2024, with support for a 505(b)(2) pathway.
Intellectual property
Formulation patents internationally by LTS Lohmann Systems AG.
Method of Use patents filed internationally by Solvonis.
SVN-SDN-14
A series of serotonin, dopamine and noradrenaline modulators under pre-clinical investigation by Solvonis. They are being assessed for potential to promote pro-social behaviour and offer an improved safety profile compared to existing treatments being developed for post-traumatic stress disorder (PTSD).
Pro-social behaviour is increasingly recognised as a key factor in addressing PTSD. Enhancing these behaviours may help individuals with PTSD overcome feelings of isolation, rebuild interpersonal relationships and engage more effectively in therapeutic interventions.
Intellectual property
Composition of matter patents filed internationally by Solvonis.