Relmada Therapeutics has acquired complete worldwide ownership rights to Sepranolone from Sweden-based Asarina Pharma. Sepranolone is a neurosteroid being developed as a potential treatment for Tourette’s syndrome (TS) and other compulsive disorders.
TS is a complex neurological condition characterised by involuntary tics.
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The asset purchase agreement between the two companies is valued at €3m ($3.12m).
The therapy has demonstrated a favourable safety profile in clinical neuro/hormonal trials with more than 335 subjects.
Relmada Therapeutics CEO Sergio Traversa stated: “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 [in] reducing tics but also improving quality of life without serious side effects.
“We have been impressed by the encouraging Phase IIa 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.”
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By GlobalDataAs a first-in-class GABAA-modulating steroid antagonist (GAMSA), Sepranolone works by normalising the activity of the GABAA receptor by targeting alpha-2 and alpha-4, the receptor subtypes.
This mechanism avoids direct interference with GABAA signalling, offering a selective treatment approach for TS and associated disorders. The therapy is under the protection of several issued patents extended until 2038.
The therapy has shown potential in improving TS symptoms in an open-label Phase IIa study compared to standard of care alone.
The changes were measured by the Yale Global Tic Severity Scale (YGTSS) scoring system, compared to the baseline.
In August 2022, the US Food and Drug Administration granted fast-track status to Relmada’s REL-1017 as a single agent for treating major depressive disorder.
