Solvonis Therapeutics (LSE:SVNS) told investors that new analysis of its Phase 2 KARE trial data show SVN-001 reduced heavy drinking days by 67% versus placebo at weeks 17-20, a statistically significant result on the endpoint European regulators use to assess Alcohol Use Disorder (AUD) treatments.
Pooled across the full 24-week follow-up, the reduction was 55%, directionally consistent but not significant on its own.
SVN-001 is Solvonis's lead candidate for severe AUD, now recruiting in a 280-participant UK Phase 3 trial co-funded with the National Institute for Health and Care Research, as the company works to reach what it calls a value-inflection point before considering European site additions.
In indirect, cross-trial comparisons, the drug's reduction in heavy drinking days exceeded naltrexone's 25% and the GLP-1 therapies pemvidutide (35%) and semaglutide (46%), achieved with a defined four-week course against ongoing weekly or monthly dosing for the comparators.
A second analysis found ketamine treatment was linked to significant reductions in craving and rumination at three months, with patients who had a family history of AUD showing a stronger response, a signal the ongoing Phase 3 trial is designed to test.
"On the endpoint EMA actually uses, it's ahead of the standard of care and the GLP-1 therapies everyone's watching", chief executive Anthony Tennyson said.
The comparisons draw on separate trials and populations, and pemvidutide's figures come from a topline release rather than peer-reviewed data.
The findings follow Solvonis's £1.3 million placing in August, which is funding an assessment of European Union sites for the SVN-001 Phase 3 study alongside progress on SVN-002, its US-focused esketamine candidate.