Policy & Regulation
Solvonis signs Portugal agreement to assess European expansion of Phase 3 alcohol addiction trial
13 October 2026 -

Solvonis Therapeutics plc (LON:SVNS), a late clinical-stage biopharmaceutical company developing small-molecule therapeutics for central nervous system (CNS) disorders, said on Tuesday that it has signed a memorandum of understanding to assess adding Portuguese sites to its MORE-KARE Phase 3 trial of SVN-001 for severe alcohol use disorder.

The agreement with ICAD, Portugal's public addiction institute, and Panegreen – Health & Wellness Solutions, Lda., which runs The Clinic of Change, a ketamine-assisted psychotherapy clinic in Lisbon, advances plans announced in August 2026 to expand the 280-participant UK trial into Europe.

SVN-001 combines ketamine with structured psychological therapy and is being evaluated in a study sponsored by the University of Exeter and co-funded by Solvonis, the National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC).

ICAD, which is attached to Portugal's Ministry of Health, will help assess patient referrals, recruitment pathways and public addiction-treatment services, while Panegreen will coordinate the Portuguese activities through its Lisbon clinic.

The assessment will examine potential trial sites, staffing, treatment delivery, training, regulatory and ethics requirements, start-up timelines and costs. Solvonis will also evaluate whether Portuguese sites could achieve per-participant costs broadly comparable to those at UK National Health Service trial sites.

Adding Portuguese participants would introduce European Union clinical data into SVN-001's Phase 3 evidence base, potentially strengthening future marketing authorisation applications in selected EU countries or across the bloc.

Solvonis will present the proposal to the University of Exeter, NIHR and MRC for consideration. The MoU has an initial six-month term and does not commit the parties to proceeding, with participation subject to sponsor and funder agreement and the necessary regulatory, ethical, contractual and funding approvals.

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