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Solvonis Therapeutics PLC on Monday announced positive pharmacokinetic data from the preclinical bridging study for its SVN-002 development programme. In response, shares in the London-based biopharmaceutical company focused on central nervous system disorders jumped 9.0% to 0.21 pence each in London on Monday. ‘This is an important technical and regulatory milestone for SVN-002,’ said Chief Executive Anthony Tennyson. ‘The study was designed to test whether our intended combined sublingual-buccal delivery could generate esketamine exposure supportive of a scientific bridge to the approved intranasal esketamine reference product. The data support that objective and provide an important basis for the next stage of regulatory engagement, including FDA feedback on the remaining toxicology package,’ he added. SVN-002 is Solvonis’ proprietary esketamine oral thin-film formulation being developed for moderate-to-severe alcohol use disorder in the US. The programme is being advanced under a planned US Food & Drug Administration regulatory pathway. Following the positive results, Solvonis will seek further FDA feedback on the scope and scale of the remaining nonclinical toxicology work required for the initial investigational new drug submission. Subject to FDA feedback, Solvonis plans to submit an IND to support the initiation of a phase 2b clinical trial of SVN-002 in patients with moderate-to-severe alcohol use disorder in the US. Copyright 2026 Alliance News Ltd. All Rights Reserved.
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