8-K: Relmada Therapeutics Acquires Sepranolone for Tourette Syndrome Treatment from Asarina Pharma AB

Relmada Therapeutics expands its CNS portfolio by acquiring Sepranolone, a Phase 2b ready asset, from Asarina Pharma AB for the treatment of Tourette Syndrome and other compulsive disorders.

Summary

• Relmada Therapeutics has acquired Sepranolone from Asarina Pharma AB for €3 million.
• Sepranolone is a Phase 2b ready neurosteroid being developed for Tourette Syndrome (TS) and other compulsive disorders.
• Phase 2a results showed a 28% reduction in tic severity (p=0.051) and improvements in quality of life compared to standard of care.
• The purchase price includes a credit of $250,000 for a previous exclusivity agreement payment.
• Relmada believes Sepranolone has the potential to become a first-line treatment for TS.
• Relmada plans to host an investor update on Sepranolone's next development steps later in 2025.

Sentiment

Score: 8

Explanation: The document presents a positive outlook due to the acquisition of a promising asset with encouraging Phase 2a data and a novel mechanism of action. The management's comments and strategic outlook further contribute to the positive sentiment.

Positives

• Sepranolone has shown promising Phase 2a results, including a 28% reduction in tic severity (p=0.051) and improved quality of life.
• Sepranolone demonstrated a robust safety data package with no CNS off-target effects.
• Sepranolone is a first-in-class compound with a novel mechanism of action.
• The acquisition aligns with Relmada's mission to find solutions for difficult-to-treat CNS disorders.
• Sepranolone is protected by multiple issued patents until 2038.

Negatives

• The Phase 2a study had a small sample size (26 subjects).
• The p-value for the primary endpoint (tic reduction) was 0.051, which is just above the conventional threshold of 0.05 for statistical significance.

Risks

• Clinical trial results may not demonstrate statistically and/or clinically significant evidence of efficacy and/or safety.
• Planned or ongoing preclinical and clinical studies may not recapitulate the results of prior studies.
• Relmada may fail to secure FDA agreement on the regulatory path for Sepranolone.
• Relmada may fail to secure adequate Sepranolone drug supply.

Future Outlook

Relmada plans to host an investor update on Sepranolone's next development steps later in 2025 and continues to evaluate additional product and strategic opportunities.

Management Comments

• Sergio Traversa, CEO of Relmada, stated that Sepranolone aligns with the company's mission to find solutions for difficult-to-treat CNS disorders and that they were impressed by the encouraging Phase 2a efficacy signal.
• Maged Shenouda, CFO of Relmada, commented that the Sepranolone transaction is an excellent fit with their objective to build shareholder value by leveraging their core competencies of identifying and developing innovative compounds.

Industry Context

The acquisition of Sepranolone positions Relmada in the Tourette Syndrome treatment market, where there is a significant unmet need for improved therapies with fewer side effects. Sepranolone's novel mechanism of action could provide a competitive advantage over existing treatments.

Comparison to Industry Standards

• Current treatments for Tourette Syndrome, such as dopamine D2 blockers and atypical antipsychotics, often have significant side effects.
• Sepranolone's Phase 2a data suggests a more favorable safety profile compared to existing treatments.
• The 28% reduction in tic severity observed in the Phase 2a study is competitive with other treatments for Tourette Syndrome.
• Companies like Teva Pharmaceutical and Neurocrine Biosciences are also developing treatments for Tourette Syndrome, making the market competitive.

Stakeholder Impact

• Shareholders may benefit from the potential increase in value due to the acquisition of a promising asset.
• Patients with Tourette Syndrome may benefit from a new treatment option with a potentially improved safety profile.
• Employees of Relmada may have new opportunities related to the development of Sepranolone.

Next Steps

• Relmada plans to advance Sepranolone into Phase 2b clinical trials.
• Relmada anticipates hosting an investor update on Sepranolone's next development steps later in 2025.
• Relmada continues to evaluate additional product and strategic opportunities.

Key Dates

Keywords

Sepranolone, Relmada Therapeutics, Asarina Pharma, Tourette Syndrome, Neurosteroid, Acquisition, CNS disorders, Phase 2b, GABAA Modulating Steroid Antagonist, Clinical Trial