Biopharmaceutical company Solvonis Therapeutics plc (LSE: SVNS) on Monday reported positive pharmacokinetic data from a preclinical bridging study supporting the development of SVN-002, its proprietary esketamine oral thin-film formulation for moderate-to-severe Alcohol Use Disorder in the United States.

This study demonstrated that combined sublingual-buccal administration of SVN-002 generated rapid systemic exposure to esketamine, with exposure levels for esketamine and key metabolites falling within the range observed for the approved intranasal esketamine comparator product, Spravato. The results are intended to support a scientific bridge under the planned US Food and Drug Administration 505(b)(2) regulatory pathway.

The data build on feedback received during a Type B pre-IND meeting with the FDA in December 2024, when systemic exposure to esketamine and relevant metabolites was identified as a key consideration for the initial Investigational New Drug submission. Solvonis said the findings strengthen its planned IND package.

Solvonis will now seek further FDA guidance on the remaining nonclinical toxicology requirements. Subject to regulatory feedback and completion of the toxicology programme, Solvonis plans to submit an IND application to support a Phase 2b trial of SVN-002 in US patients with moderate-to-severe Alcohol Use Disorder.

According to the company, the 505(b)(2) pathway could provide a more capital-efficient development route by leveraging existing third-party preclinical data, in-licensed Phase 1 clinical data and targeted bridging studies, rather than undertaking a full de novo development programme.