"Sepranolone, a GAMSA targeting the GABAA pathway, has shown potential in improving Tourette syndrome symptoms, based on data from a Phase 2a study Biotechnology company Relmada Therapeutics has acquired investigational neurosteroid Sepranolone (isoallopregnanolone) from Sweden-based Asarina Pharma for €3m.
Sepranolone is a Phase 2b-ready asset being developed for Tourette syndrome (TS) and other compulsive disorders.
As per the terms of this asset purchase agreement, Nasdaq-listed Relmada Therapeutics has purchased full global ownership rights to Sepranolone.
Relmada Therapeutics CEO Sergio Traversa said: “We are very pleased to announce this agreement with Asarina. Sepranolone aligns with our Company’s mission to find solutions for difficult-to-treat central nervous system (CNS) disorders.
“There is a serious unmet need for improved TS therapies not only reducing tics but also improving quality of life without serious side effects.
“We have been impressed by the encouraging Phase 2a efficacy signal with clinically meaningful tic reductions and quality-of-life improvements, combined with a robust safety data package showing no CNS off-target effects, that we believe reflect the compound’s selective binding properties.”
Sepranolone is a GABAA Modulating Steroid Antagonist (GAMSA). It targets the GABAA pathway to counteract Allopregnanolone, a neurosteroid linked to TS and other compulsion-related conditions.
Data from an open-label Phase 2a randomised study has showed Sepranolone’s potential to improve TS symptoms compared to standard care.
In this 12-week, dual-centre trial, 26 subjects received Sepranolone alongside standard of care.
The Phase 2a results showed Sepranolone reduced tic severity by 28% and improved quality of life, with no CNS off-target effects.
The asset also achieved positive outcomes in four key secondary endpoints, outperforming standard of care.
Asarina Pharma CEO Peter Nordkild said: “We strongly believe that it has the potential to become a first-line pharmaceutical therapy for TS, significantly improving quality of life for TS patients.
“While we would have liked Asarina to continue the development of Sepranolone, we are confident that Relmada is well suited to bring the compound forward towards regulatory approval and commercialisation.”
In December 2024, Relmada Therapeutics announced plans to discontinue the Reliance II and Relight Phase 3 studies following a data monitoring committee review of the REL-1017 programme.
The company will continue advancing the Phase 1 study of REL-P11, an investigational treatment for metabolic disease.