Relmada Therapeutics, a clinical-stage biotechnology company, has acquired Sepranolone, a Phase 2b ready neurosteroid, from Asarina Pharma, being developed for the potential treatment of Tourette syndrome (TS) and other compulsive disorders.
Sergio Traversa, Chief Executive Officer of Relmada, 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.
“We believe that this transaction is an excellent fit with our objective to build shareholder value by leveraging our core competencies of identifying and developing innovative compounds.”
Luca Pani, MD, Professor of Clinical Psychiatry at the University of Miami Miller School of Medicine, said: “While current treatments for Tourette syndrome provide only modest tic reduction and are often accompanied by significant side effects, the Phase 2a data suggest that Sepranolone has the potential to offer meaningful symptom relief with a more favorable safety profile. These findings are promising, and I look forward to seeing further clinical development of this novel therapy.”
“Late last year we announced that Relmada would explore strategic assets and strategic options,” said Maged Shenouda, Chief Financial Officer of Relmada. “Based on our extensive due diligence, including a carefully conducted review of the clinical and regulatory data, and consultation with well-respected outside experts, we believe the promising Phase 2a data suggest that Sepranolone has the potential to become first line treatment for TS.”
Sepranolone (isoallopregnanolone) is a first-in-class GABAA Modulating Steroid Antagonist (GAMSA), which selectively targets the GABAA (GABAA) pathway to counteract the effects of Allopregnanolone, a neurosteroid implicated in TS and other compulsive disorders.
Data from an open-label Phase 2a randomized study demonstrated that Sepranolone has the potential to improve TS symptoms versus standard of care alone, as measured by changes in the YGTSS scoring system (the world-standard Yale Global Tic Severity Scale) compared to baseline. In the 12-week, dual-center, parallel-group study, 26 subjects were treated with Sepranolone 10 mg, administered by subcutaneous injection twice weekly in addition to standard of care (SOC) versus standard of care alone.
The Phase 2a results showed competitive tic reduction and improved quality of life while displaying no CNS off-target effects.
Under the terms of the agreement, Relmada acquired full global ownership rights to Sepranolone from Asarina Pharma through an asset purchase agreement for EUR 3 million.
