'We continue to make solid progress in advancing our ongoing Phase 3 program for REL-1017 as an adjunctive treatment for major depressive disorder (MDD),' said
'In our promising low dose metabolic psilocybin program (REL-P11) , which showed significant therapeutic potential on multiple parameters in pre-clinical rodent studies, we intend to initiate a single-ascending dose Phase 1 trial in obese patients in the first half of this year to define the pharmacokinetic, safety, and tolerability profile of our modified-release psilocybin formulation in this population,' continued
Recent Corporate Highlights
Presented new preclinical data on its novel psilocybin at the American Association for the Study of Liver Diseases (AASLD)
Appointed Dr.
Upcoming Anticipated Milestones
Complete enrollment in ongoing RELIANCE II, which is planned to enroll approximately 300 patients, with top-line data in the second half of 2024.
Complete enrollment in the Relight study (study 304), which is planned to enroll approximately 300 patients, by year-end 2024.
Commence a Phase 1 trial in obese patients in the first half of 2024 to define the pharmacokinetic, safety and tolerability profile of the Company's modified-release psilocybin formulation (REL-P11), followed by a Phase 2a trial to establish clinical proof-of-concept with data expected in the first half of 2025.
Fourth Quarter 2023 Financial Results
Research and development expense for the three months ended
General and administrative expense for the three months ended
Net cash used in operating activities for the three months ended
The net loss for the three months ended
Full-Year 2023 Financial Results
Research and development expense for the year ended
General and administrative expense for the year ended
Net cash used in operating activities for the year ended
Net loss for the year ended
As of
About REL-1017
REL-1017, a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is currently in late-stage development for the adjunctive treatment of major depressive disorder (MDD). Relmada's ongoing clinical research program is designed to evaluate the potential for REL-1017 as a rapid-acting, oral, once-daily antidepressant treatment. The development program for REL-1017 as an adjunctive treatment for MDD includes two Phase 3 randomized, double-blind, placebo-controlled studies, Reliance II (Study 302) and Relight (Study 304). Reliance II and Relight have the same key study design parameters.
About REL-P11
Relmada acquired the development and commercial rights to a novel psilocybin and derivatives program in July of 2021. Psilocybin has neuroplastogen effects that have the potential to ameliorate neurodegenerative conditions. The pleiotropic metabolic effects of low-dose psilocybin were discovered while studying its neuroplastogen potential in a rodent model deficient in neurogenesis - obese rats maintained on a high fructose, high fat diet (HFHFD), and were then replicated in mice.
About
Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as 'expects,' 'anticipates,' 'believes,' 'will,' 'will likely result,' 'will continue,' 'plans to,' 'potential,' 'promising,' and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including potential failure of clinical trial results to demonstrate statistically and/or clinically significant evidence of efficacy and/or safety, failure of top-line results to accurately reflect the complete results of the trial, failure of the 310 open-label study to accurately reflect the results of the ongoing 302 and 304 blinded, randomized and controlled studies, failure to obtain regulatory approval of REL-1017 for the treatment of major depressive disorder, failure of the planned psilocybin Phase 1 and Phase 2a trials to be successfully initiated and carried out, and the other risk factors described under the heading 'Risk Factors' set forth in the Company's reports filed with the
Contact:
Email: Tim@LifeSciAdvisors.com
Email: media@relmada.com
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