Relmada Therapeutics Advances Phase 1 Study of REL-P11

Relmada Therapeutics Begins Phase 1 Dosing of REL-P11

Relmada Therapeutics, Inc. (NASDAQ: RLMD) is making strides in the fight against metabolic diseases with the recent initiation of dosing in a Phase 1 Single-Ascending Dosing (SAD) study for REL-P11. This proprietary, low-dose, modified-release psilocybin formulation aims to evaluate safety and pharmacokinetics in both obese and normal weight subjects.

Significance of the Phase 1 Study

The commencement of this Phase 1 study marks a pivotal moment for Relmada. The company’s CEO, Sergio Traversa, emphasized the importance of this milestone, stating, “Dosing of the first subjects in the Phase 1 study is an important milestone for REL-P11.” Previous preclinical studies conducted in 2023 demonstrated that the treatment improved multiple metabolic parameters without causing adverse effects on the central nervous system (CNS).

Potential of REL-P11

The findings suggest that REL-P11 could soon become a significant therapeutic option for tackling obesity and metabolic syndrome. If the initial data from this study is positive, Relmada plans to move on to a Phase 2a proof-of-concept study.

Exploring REL-P11's Mechanism

Relmada Therapeutics acquired the developmental and commercial rights for the novel psilocybin formulation and its derivatives in July 2021. Psilocybin is known for its neuroplastic properties, which may offer relief in neurodegenerative conditions. The research team at Relmada recognized the opportunity to utilize low-dose psilocybin as an innovative treatment for metabolic diseases and presented their findings at the American Society for the Study of Liver Disease.

Company’s Commitment to Neuroscience

Relmada is a late-stage biotechnology company focused primarily on diseases that affect the CNS, particularly major depressive disorder (MDD). Relmada is not only pioneering treatments like REL-P11 but also advancing their lead program, REL-1017, which is currently undergoing late-stage development as an adjunctive treatment for adults suffering from MDD.

About Relmada Therapeutics

With a dedicated and experienced team, Relmada Therapeutics is committed to making a measurable difference in the lives of patients affected by CNS diseases. Their innovative approach involves targeting hyperactive NMDA receptor channels through REL-1017, designed to sustain natural glutamatergic neurotransmission. This unique strategy is exemplified in their commitment to addressing significant mental health issues faced by many individuals.

Looking Forward

As the Phase 1 study unfolds, the Relmada team remains optimistic about the potential advancements in metabolic treatments. The data gathered will inform future clinical trials and bolster their efforts toward developing groundbreaking therapies for patients in need. Stakeholders and health professionals alike are keenly observing the outcomes as they anticipate the next advancements in Relmada’s research journey.

Frequently Asked Questions

What is REL-P11?

REL-P11 is a proprietary, low-dose, modified-release formulation of psilocybin developed by Relmada Therapeutics for the treatment of metabolic diseases.

What is the aim of the Phase 1 study?

The Phase 1 study aims to evaluate the safety, tolerability, and pharmacokinetic profile of REL-P11 in various patient populations.

What were the findings from previous studies?

Preclinical studies indicated that REL-P11 improved metabolic parameters without adverse CNS effects, suggesting its potential for treatment.

What other treatments is Relmada pursuing?

In addition to REL-P11, Relmada is developing REL-1017, a treatment for major depressive disorder, utilizing unique mechanisms to target hyperactive NMDA receptors.

When can we expect the Phase 2a study to start?

If the Phase 1 results are favorable, the Phase 2a proof-of-concept study is expected to commence in the near future.

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