Relmada initiates Phase 1 study for REL-P11, a psilocybin formulation for metabolic disorders, with Phase 2a planned for 2025.
Quiver AI Summary
Relmada Therapeutics has announced the initiation of dosing in a Phase 1 Single-Ascending Dosing study of its investigational low-dose, modified-release psilocybin formulation, REL-P11, aimed at treating metabolic diseases in both obese and normal weight subjects. This milestone follows promising preclinical results that showed REL-P11 improved various metabolic parameters without harmful effects on the central nervous system. The company’s CEO, Sergio Traversa, expressed optimism that the Phase 1 study will clarify the safety and pharmacokinetics of REL-P11 and set the stage for a Phase 2a proof-of-concept study expected to start in early 2025. Relmada, a late-stage biotechnology firm focused on central nervous system disorders, continues to advance its portfolio, which includes the lead program REL-1017 for major depressive disorder.
Potential Positives
- The initiation of the Phase 1 Single-Ascending Dosing (SAD) study for REL-P11 represents a significant milestone for Relmada Therapeutics, indicating progress in their drug development pipeline.
- Positive preclinical data presented at AASLD 2023 suggests that REL-P11 could offer improvements in metabolic parameters without detrimental effects on the central nervous system, enhancing its therapeutic potential.
- Anticipation of a Phase 2a proof-of-concept study beginning in H1 2025 provides an optimistic future outlook for the investigational agent within the obesity and metabolic syndrome treatment space.
Potential Negatives
- The press release contains multiple forward-looking statements that highlight significant risks, including the potential failure of the ongoing Phase 1 trial and subsequent Phase 2a trials of REL-P11, which could hinder the development of this investigational agent.
- There is a lack of historical data supporting the efficacy and safety of REL-P11 as an effective treatment for metabolic diseases, with reliance on preclinical studies that may not translate to human results.
- Failure to successfully execute the ongoing clinical studies could lead to regulatory approval delays, impacting investor confidence and the company's market position.
FAQ
What is REL-P11?
REL-P11 is a low-dose, modified-release psilocybin formulation for evaluating safety in metabolic disease treatment.
When will the Phase 2a study of REL-P11 start?
The Phase 2a proof-of-concept study for REL-P11 is expected to begin in H1 2025.
What were the preclinical results of REL-P11?
Preclinical rodent studies showed REL-P11 improved metabolic parameters without detrimental effects on the CNS.
Who is leading Relmada Therapeutics?
Sergio Traversa is the Chief Executive Officer of Relmada Therapeutics, overseeing its focus on CNS diseases.
What is Relmada's lead program?
Relmada's lead program is REL-1017, a new chemical entity for treating major depressive disorder in adults.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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