Solvonis Reports Positive SVN-002 Bridging Data for Alcohol Use Disorder

Solvonis Therapeutics (LSE:SVNS) announced positive bridging pharmacokinetic data from its SVN-002 program, repurposing Johnson & Johnson's approved esketamine treatment Spravato for moderate to severe alcohol use disorder via the FDA's 505(b)(2) pathway. The company plans to file an Investigational New Drug (IND) application for a Phase 2b trial in the US.

The Product

SVN-002 delivers esketamine sublingually or buccally. Preclinical PK studies showed comparable exposure levels of esketamine and its metabolites versus intranasal administration. CEO Anthony Tennyson stated, "We've established that esketamine delivered sublingual and buccal delivers the same exposure as esketamine delivered intranasal." This is a key step in establishing the scientific bridge required by the FDA.

Pricing and Availability

Solvonis has not yet disclosed pricing or commercial availability for SVN-002. The development path via the 505(b)(2) pathway could accelerate timelines and reduce costs.

Competition

SVN-002 targets a large market of approximately 15 million US adults with alcohol use disorder, far larger than Spravato's current market for treatment-resistant depression. No esketamine-based treatments are currently approved for this indication.

Potential Impact

Tennyson noted the data could support a narrower toxicology package and a faster, capital-efficient development timeline. Next steps include FDA discussions on toxicology requirements ahead of an IND submission for the planned Phase 2b trial.