SVN-001

About SVN-001

SNV-001 is a Phase 3 investigational, novel combination therapy consisting of an N-methyl-D-aspartate ("NMDA") receptor-modulating drug (ketamine) delivered intravenously ("IV") in combination with copywritten relapse prevention cognitive behavioural therapy ("CBT") for the treatment of severe AUD for the UK and EU markets.

Clinical evidence

Phase 2 results demonstrated a 50% reduction in Heavy Drinking Days vs a placebo.

Long-term impact: 86% abstinence on average sustained for six months post-treatment, compared to just 2% pre-trial.

Regulatory pathway

A full mixed marketing authorisation in the UK and EU is planned, which, if successful, will provide regulatory protection to include eight years of data exclusivity in the EU and ten years of concurrent market exclusivity in both regions.

Clinical development

SVN-001 is in phase 3, with an n=280 two-armed active placebo-controlled ‘More Kare’ trial. It is co-funded by the UK National Institute for Health Research Efficacy and Mechanism Evaluation Programme (NIHR150193) and Solvonis. It is being run by the University of Exeter Clinical Trials Unit.

SVN-001

SVN-001 Phase III Estimated Trial Design
Timeline of a clinical trial process with four milestones marked along a horizontal line. From left to right: (1) ‘Phase 3 Regulatory/Ethical Approval’ in H2 2023, (2) ‘Patient Enrolment Began’ in Q3 2024, (3) ‘Trial Completion’ forecasted for 2026–27, and (4) ‘UK/EU Marketing Authorisation Submission’ forecasted for 2028/2029. Each milestone is connected by a vertical line to a white circle on the timeline, against a light blue background.
Timeline of a clinical trial process with four milestones marked along a horizontal line. From left to right: (1) ‘Phase 3 Regulatory/Ethical Approval’ in H2 2023, (2) ‘Patient Enrolment Began’ in Q3 2024, (3) ‘Trial Completion’ forecasted for 2026–27, and (4) ‘UK/EU Marketing Authorisation Submission’ forecasted for 2028/2029. Each milestone is connected by a vertical line to a white circle on the timeline, against a light blue background.
Timeline of a clinical trial process with four milestones marked along a horizontal line. From left to right: (1) ‘Phase 3 Regulatory/Ethical Approval’ in H2 2023, (2) ‘Patient Enrolment Began’ in Q3 2024, (3) ‘Trial Completion’ forecasted for 2026–27, and (4) ‘UK/EU Marketing Authorisation Submission’ forecasted for 2028/2029. Each milestone is connected by a vertical line to a white circle on the timeline, against a light blue background.
Timeline of a clinical trial process with four milestones marked along a horizontal line. From left to right: (1) ‘Phase 3 Regulatory/Ethical Approval’ in H2 2023, (2) ‘Patient Enrolment Began’ in Q3 2024, (3) ‘Trial Completion’ forecasted for 2026–27, and (4) ‘UK/EU Marketing Authorisation Submission’ forecasted for 2028/2029. Each milestone is connected by a vertical line to a white circle on the timeline, against a light blue background.
Timeline of a clinical trial process with four milestones marked along a horizontal line. From left to right: (1) ‘Phase 3 Regulatory/Ethical Approval’ in H2 2023, (2) ‘Patient Enrolment Began’ in Q3 2024, (3) ‘Trial Completion’ forecasted for 2026–27, and (4) ‘UK/EU Marketing Authorisation Submission’ forecasted for 2028/2029. Each milestone is connected by a vertical line to a white circle on the timeline, against a light blue background.

SVN-001 Ph3 trial design

  • n=280 two-armed placebo-controlled trial.

  • Trial co-funded by UK Dept of Health and Social Care.

  • Cost to Solvonis of Phase 3 capped at only £800,000.

  • Nine NHS Trust Sites.

  • Trial started Q3 2024.

  • MHRA innovative passport (ILAP) awarded.

SVN-001 Ph3 trial design

SVN-001 Phase III Trial Design
Flow diagram showing the structure of a clinical trial from enrolment to follow-up. At the top, 800 individuals undergo telephone screening, followed by 420 undergoing in-person screening. Those who proceed receive support to remain abstinent, with 280 participants eventually randomised into two groups.  The ‘Active’ group receives three infusions of 0.8 mg/kg ketamine along with seven 1.5-hour sessions of psycho-social support. The ‘Placebo’ group receives three infusions of 0.05 mg/kg ketamine along with alcohol education.  Both groups are followed up at 3, 6, and 9 months. Vertical sections label the phases as: Enrolment, Allocation, Interim Analysis, and Follow Up, with arrows tracing participant progress through each phase.
Flow diagram showing the structure of a clinical trial from enrolment to follow-up. At the top, 800 individuals undergo telephone screening, followed by 420 undergoing in-person screening. Those who proceed receive support to remain abstinent, with 280 participants eventually randomised into two groups.  The ‘Active’ group receives three infusions of 0.8 mg/kg ketamine along with seven 1.5-hour sessions of psycho-social support. The ‘Placebo’ group receives three infusions of 0.05 mg/kg ketamine along with alcohol education.  Both groups are followed up at 3, 6, and 9 months. Vertical sections label the phases as: Enrolment, Allocation, Interim Analysis, and Follow Up, with arrows tracing participant progress through each phase.
Flow diagram showing the structure of a clinical trial from enrolment to follow-up. At the top, 800 individuals undergo telephone screening, followed by 420 undergoing in-person screening. Those who proceed receive support to remain abstinent, with 280 participants eventually randomised into two groups.  The ‘Active’ group receives three infusions of 0.8 mg/kg ketamine along with seven 1.5-hour sessions of psycho-social support. The ‘Placebo’ group receives three infusions of 0.05 mg/kg ketamine along with alcohol education.  Both groups are followed up at 3, 6, and 9 months. Vertical sections label the phases as: Enrolment, Allocation, Interim Analysis, and Follow Up, with arrows tracing participant progress through each phase.
Flow diagram showing the structure of a clinical trial from enrolment to follow-up. At the top, 800 individuals undergo telephone screening, followed by 420 undergoing in-person screening. Those who proceed receive support to remain abstinent, with 280 participants eventually randomised into two groups.  The ‘Active’ group receives three infusions of 0.8 mg/kg ketamine along with seven 1.5-hour sessions of psycho-social support. The ‘Placebo’ group receives three infusions of 0.05 mg/kg ketamine along with alcohol education.  Both groups are followed up at 3, 6, and 9 months. Vertical sections label the phases as: Enrolment, Allocation, Interim Analysis, and Follow Up, with arrows tracing participant progress through each phase.
Flow diagram showing the structure of a clinical trial from enrolment to follow-up. At the top, 800 individuals undergo telephone screening, followed by 420 undergoing in-person screening. Those who proceed receive support to remain abstinent, with 280 participants eventually randomised into two groups.  The ‘Active’ group receives three infusions of 0.8 mg/kg ketamine along with seven 1.5-hour sessions of psycho-social support. The ‘Placebo’ group receives three infusions of 0.05 mg/kg ketamine along with alcohol education.  Both groups are followed up at 3, 6, and 9 months. Vertical sections label the phases as: Enrolment, Allocation, Interim Analysis, and Follow Up, with arrows tracing participant progress through each phase.

Ph2 results