Solvonis Therapeutics has reported new analyses of its Phase 2 KARE trial showing that patients receiving SVN-001 had 67% fewer heavy drinking days than placebo during weeks 17 through 20 of follow-up.
The result was statistically significant with a p-value of 0.018 and was observed more than four months after patients received their final infusion in the four-week treatment course.
Across weeks 17 through 24, the reduction in heavy drinking days was 55%. The company noted that this broader pooled result did not reach conventional statistical significance on its own, with a p-value of 0.062.
Solvonis also reported that the percentage of days abstinent increased significantly across every measurement window analyzed.
The company is developing SVN-001 for severe Alcohol Use Disorder and is using the new analyses to support its planned expansion in Europe.
Solvonis said the heavy-drinking-day endpoint is used by European regulators when evaluating reduction-focused AUD treatments.
A separate analysis of KARE data found that ketamine treatment was associated with significant reductions in craving and rumination three months after treatment.
Patients with a family history of Alcohol Use Disorder showed stronger responses on both measures. Solvonis described that result as hypothesis-generating because the analysis involved a small sample and was not designed to establish that family history predicts treatment response.
The company’s comparisons with other treatments were based on separate studies rather than head-to-head trials.
Solvonis said SVN-001’s 67% reduction exceeded reported relative reductions of 25% for naltrexone, 35% for investigational GLP-1 therapy pemvidutide and 46% for semaglutide across two randomized trials.
The company cautioned that differences among the studies and patient populations mean those comparisons do not establish comparative efficacy.
Solvonis is currently enrolling the 280-patient MORE-KARE Phase 3 trial in the UK. The trial is being co-funded with the National Institute for Health and Care Research.
The company is also advancing SVN-002, an esketamine oral thin-film formulation targeting the U.S. market, toward Phase 2 development following a pre-IND meeting with the FDA.
SVN-001 and SVN-002 remain investigational and are not approved for use.
KEY QUOTES:
“SVN-001 now has both a mechanism and data. It eases the craving and negative thinking that drive relapse — and on the endpoint EMA actually uses, it’s ahead of the standard of care and the GLP-1 therapies everyone’s watching. That’s the foundation for the European expansion we’re building. The human and economic cost of AUD is enormous: in England alone, it is estimated to cost over £27bn a year, with £4.9bn of that falling on the NHS. This is a crisis that needs tackling, and we believe SVN-001 can be an integral part of the solution.”
Anthony Tennyson, Chief Executive Officer of Solvonis Therapeutics
“It’s one thing to show a treatment works. It’s another to understand why, and to know how it compares. These analyses give us all three — and the family-history finding starts to tell us who might benefit most, which is exactly what Phase 3 is designed to test.”
Professor David Nutt, Chief Scientific Officer of Solvonis Therapeutics
