Solvonis Therapeutics PLC (LSE:SVNS) has kicked off a series of regulatory studies to support the development of its lead treatment for alcohol addiction, marking a significant step toward clinical trials in the United States.
The London-listed company said on Tuesday it had initiated a pharmacokinetic programme for SVN‑002, its sublingual esketamine oral thin film, which is being developed as a treatment for moderate to severe alcohol use disorder when used alongside psychosocial therapy.
The studies are designed to provide scientific “bridging” data linking SVN‑002 to Janssen’s Spravato, a nasal spray version of esketamine already approved in the US.
By referencing the existing drug, Solvonis aims to pursue the 505(b)(2) regulatory pathway, a route that allows companies to rely on existing data to streamline approval processes.
SVN‑002 was originally developed by Awakn Life Sciences, which held a pre-Investigational New Drug (IND) meeting with the US Food and Drug Administration in December.
Solvonis acquired the asset earlier this year as part of its takeover of Awakn and is now preparing for a phase IIb trial in the US.
Solvonis has appointed WuXi AppTec, a contract research and manufacturing company listed in Hong Kong and Shanghai, to run the pharmacokinetic studies.
These tests will measure how the drug is absorbed and processed in the body and are a requirement before the company can proceed with an IND submission to the FDA.
Professor David Nutt, Solvonis' chief scientific officer, told investors: "This translational programme is a critical milestone in delivering on the FDA's feedback, which was received during our pre-IND meeting."
The US market for alcohol use disorder remains large and underserved, with an estimated 29 million people affected, according to the company.