Relmada buys Tourette's treatment rights from Asarina

Relmada Therapeutics has recently expanded its portfolio by acquiring the global rights to Sepranolone from Asarina Pharma, a company based in Sweden. Sepranolone is a neurosteroid that is being explored as a potential treatment for Tourette's syndrome (TS) and other compulsive disorders. This acquisition, valued at €3 million ($3.12 million), is a strategic move to address the demand for more effective therapies for TS, a neurological disorder characterized by involuntary tics.

The deal reflects Relmada's commitment to finding innovative solutions for central nervous system (CNS) disorders that are traditionally difficult to treat. According to Relmada's CEO, Sergio Traversa, there is a significant unmet need for TS treatments that not only reduce tics but also enhance patients' quality of life without causing serious side effects. Sepranolone has shown promise in this regard, having demonstrated a favorable safety profile in clinical trials involving over 335 participants. The trials indicated that the therapy has no CNS off-target effects, which is attributed to its selective binding properties.

Sepranolone distinguishes itself as a first-in-class GABAA-modulating steroid antagonist (GAMSA). It functions by normalizing the activity of the GABAA receptor, specifically targeting the alpha-2 and alpha-4 receptor subtypes. This mechanism allows Sepranolone to provide a selective treatment approach for TS and other related disorders without directly interfering with GABAA signaling.

The potential of Sepranolone in alleviating TS symptoms has been highlighted in an open-label Phase IIa study. In this study, the therapy was compared to the standard of care alone, and improvements were measured using the Yale Global Tic Severity Scale (YGTSS) scoring system. The results were encouraging, indicating clinically meaningful reductions in tics and enhancements in the quality of life for the patients involved.

The development of Sepranolone is further protected by multiple patents, which extend until 2038, ensuring a long-term potential for the therapy. This protection underscores the innovative nature of Sepranolone's approach to treating TS, emphasizing its unique mechanism of action.

While Sepranolone is a significant addition to Relmada's portfolio, the company is also making strides with another treatment, REL-1017. In August 2022, the US Food and Drug Administration granted fast-track status to REL-1017 as a single agent therapy for major depressive disorder. This status reflects the therapy's potential to meet an unmet medical need and its promise in addressing a critical area of mental health.

Relmada's acquisition of Sepranolone and the development of REL-1017 underscore the company's dedication to advancing treatments for CNS disorders. By focusing on innovative therapies with robust safety profiles and significant efficacy signals, Relmada aims to improve the lives of individuals suffering from these challenging conditions. The acquisition from Asarina Pharma is a testament to this commitment, marking a promising step forward in the treatment of Tourette's syndrome and related disorders.