Solvonis reports positive SVN-002 bridging data; CEO outlines next steps

Solvonis Therapeutics (LSE:SVNS) CEO Anthony Tennyson joined Proactive's Stephen Gunnion to discuss positive bridging pharmacokinetic data from the SVN-002 programme and what it means for the company's strategy in alcohol use disorder. Solvonis is advancing SVN-002 toward a Phase 2b trial for moderate to severe alcohol use disorder in the US, repurposing Johnson & Johnson's approved esketamine treatment Spravato via the FDA's 505(b)(2) pathway. Preclinical PK studies showed comparable exposure levels of esketamine and its metabolites via sublingual and buccal delivery compared with intranasal administration — a key step in establishing the scientific bridge the FDA requires. "We've established that esketamine delivered sublingual and buccal delivers the same exposure as esketamine delivered intranasal," Tennyson said. He pointed to a substantial commercial opportunity, with alcohol use disorder affecting around 15 million American adults, a far larger market than the treatment-resistant depression population Spravato currently serves. Tennyson said 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 application for the planned Phase 2b trial. For more Proactive interviews and market insights, visit the Proactive YouTube channel. Don't forget to like this video, subscribe to the channel and enable notifications so you never miss future content. #SolvonisTherapeutics #AnthonyTennyson #SVN002 #AlcoholUseDisorder #AUD #Biotech #Pharma #DrugDevelopment #Esketamine #Spravato #ClinicalTrials #FDA #HealthcareInnovation #LifeSciences #Investing