Relmada Therapeutics Acquires Tourette Therapy from Asarina Pharma
Relmada Therapeutics, Inc., a biotechnology company in the clinical development phase, has announced the acquisition of Sepranolone, a neurosteroid prepared for Phase 2b trials. This asset was purchased from Asarina Pharma AB and is being developed to potentially treat Tourette syndrome (TS) and other disorders related to compulsive behaviors.
Sepranolone, known scientifically as isoallopregnanolone, represents a groundbreaking category of compounds called GABAA Modulating Steroid Antagonists (GAMSAs). These compounds interact specifically with the GABAA pathway in the brain. By targeting this pathway, Sepranolone may offset the negative effects of Allopregnanolone, a neurosteroid implicated in TS and other compulsive conditions.
The Phase 2a clinical trial of Sepranolone yielded encouraging results, demonstrating not only improvement in Tourette symptoms but also enhancements in patients' quality of life. Moreover, the safety profile of Sepranolone was robust, with no observed off-target effects in the central nervous system (CNS). This promising data positions Sepranolone as a potential first-line treatment for Tourette syndrome, offering a new alternative to existing therapies that often come with significant side effects.
Sergio Traversa, the CEO of Relmada, expressed enthusiasm about the acquisition, highlighting the company's mission to address challenging CNS disorders. He noted the unmet need for improved treatments for Tourette syndrome, which not only mitigate tics but also enhance quality of life without causing serious adverse effects. The Phase 2a data, showing significant tic reduction and improved life quality, combined with positive safety results, underscore Sepranolone's potential.
Luca Pani, MD, a Clinical Psychiatry Professor at the University of Miami, emphasized that current Tourette treatments offer only limited tic reduction and are often associated with severe side effects. The Phase 2a findings for Sepranolone suggest it could provide meaningful symptom relief with a more favorable safety profile.
The latest clinical data on Sepranolone comes from an open-label Phase 2a randomized study. This study compared Sepranolone in conjunction with standard care against standard care alone. Conducted over 12 weeks with 26 participants, the study revealed a competitive reduction in tics and improved quality of life. Importantly, Sepranolone did not result in any CNS off-target effects.
The results showed a 28% reduction in tic severity based on the Yale Global Tic Severity Scale (YGTSS), along with substantial improvements in secondary endpoints like quality of life and reduction of premonitory urges to tic. These outcomes were achieved without systemic side effects, making Sepranolone a promising candidate for further development.
Relmada Therapeutics plans to continue exploring additional product and strategic opportunities. The company is expected to conduct an investor update on Sepranolone’s next development steps later in 2025.
Under the terms of the agreement with Asarina Pharma AB, Relmada acquired the global rights to Sepranolone for EUR 3 Million. Sepranolone has been evaluated in several clinical studies involving over 335 participants, consistently demonstrating a favorable safety profile.
Tourette syndrome, characterized by involuntary tics, affects over 350,000 children in the U.S. alone. The condition is complex, with genetic, environmental, and neurochemical influences, including the role of Allopregnanolone in compulsive behaviors. Current treatments often target neurotransmitters like dopamine but can lead to significant side effects. Sepranolone's unique mechanism, modulating Allopregnanolone, offers a potentially safer alternative.
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