Solvonis Therapeutics (LSE:SVNS), a late clinical-stage biopharmaceutical company developing small-molecule therapeutics for central nervous system disorders, has signed a Memorandum of Understanding with ICAD, Portugal's public addiction institute, and clinical partner Panegreen.
The agreement will assess adding Portuguese sites to MORE-KARE, the UK Phase 3 trial of SVN-001 for severe alcohol use disorder, which combines ketamine with structured psychological therapy.
The move turns into a signed framework the European expansion plan Solvonis first announced on 25 August, when it raised £1.3 million gross via placing partly to fund the assessment of adding EU sites to the trial.
ICAD, attached to Portugal's Ministry of Health, will help assess referral pathways and patient recruitment, while Panegreen, which runs The Clinic of Change ketamine-assisted psychotherapy clinic in Lisbon, will coordinate the Portuguese work.
The assessment will cover potential investigators, treatment delivery, pharmacy and controlled-drug requirements, regulatory and ethics requirements, start-up timelines and indicative costs, including whether cost per participant could run broadly in line with UK NHS trial sites.
Adding EU patient data to the trial is intended to strengthen the evidence base supporting future marketing authorisation applications in selected EU countries or across the bloc.
MORE-KARE is a 280-participant UK trial sponsored by the University of Exeter and co-funded by Solvonis, the National Institute for Health and Care Research and the Medical Research Council; with ICAD now involved, the programme has public-sector partners in both the UK and Portugal.
The MoU runs for an initial six-month term and does not bind Solvonis to proceed with Portuguese participation, which remains subject to sponsor and funder agreement and further ethics, regulatory, contractual and governance approvals.
Solvonis will next take the proposal to the University of Exeter, NIHR and MRC.
"Having Portugal's national addiction institute alongside us is a strong vote of confidence in our European plans for SVN-001," said Anthony Tennyson, chief executive of Solvonis Therapeutics.