Relmada Therapeutics, Inc. (Nasdaq: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced the completion of its End-of-Pha
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NEW YORK, May 27, 2020 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced the completion of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on its development program of REL-1017 (dextromethadone) for the adjunctive treatment of major depressive disorder (MDD) patients. The Company can proceed into Phase 3 without conducting additional clinical studies, and the FDA and Relmada are aligned on all key aspects of this planned Phase 3 program. Key points of the Phase 3 program discussed and agreed upon by the FDA and the Company include:
"The End-of-Phase 2 meeting with the Division provided valuable guidance for the Phase 3 program of REL-1017. Of significance, there was agreement on the primary endpoint of the MADRS score at day-28, after continuous daily administration, as the primary efficacy endpoint for regulatory approval for continuous chronic use. The MADRS score reduction at day-7 would capture the rapid onset of action as the key secondary endpoint," said Maurizio Fava, MD, Chief of the Department of Psychiatry at Massachusetts General Hospital, who will serve as the lead Principal Investigator for upcoming Phase 3 studies. Dr. Marc de Somer, medical lead at Relmada Therapeutics, added: "We have a unique opportunity to demonstrate the rapid and sustained effect of REL-1017 in the treatment of major depressive disorder. Our team aims to initiate twin pivotal studies in the United States and in Europe as quickly as possible." "We are determined to work closely with the FDA and complete the Phase 3 program to submit our NDA dossier for this initial indication. Based on the compelling clinical data generated to-date, we believe REL-1017 has the potential to be a paradigm changing treatment option for patients who suffer from MDD, and we look forward to the further clinical evaluation of this promising drug candidate," commented Dr. Thomas Wessel, Head of R&D at Relmada. About dextromethadone (REL-1017) REL-1017 is a non-competitive N-methyl-D-aspartate Receptor (NMDAR) antagonist with the potential to be the first oral single agent NMDAR antagonist approved for the adjunctive treatment of MDD. In a Phase 2 trial, REL-1017 demonstrated rapid onset and sustained antidepressant effects with statistically significant improvements as compared to placebo on efficacy measures. The Phase 2 study also confirmed the favorable safety and tolerability profile of REL-1017 observed in previously completed Phase 1 studies. In April 2017, the FDA granted Fast Track designation for dextromethadone for the adjunctive treatment of major depressive disorder. About Relmada Therapeutics, Inc. Relmada Therapeutics is a clinical-stage, publicly traded biotechnology company developing novel medicines to address areas of high unmet medical need in the treatment of central nervous system (CNS) diseases. Relmada's lead program, dextromethadone (REL-1017), is an N-methyl-D-aspartate (NMDA) receptor antagonist in development for the treatment of depression. NMDA receptor antagonists may have utility in the treatment of a range of psychiatric and neurological disorders associated with a variety of cognitive, neurological and behavioral symptoms. 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, including but not limited to statements regarding the expected use of the proceeds from the offering. 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 the risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list. Investor Contact: Tim McCarthy For Media Inquiries:
SOURCE Relmada Therapeutics, Inc. |
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Company Codes: NASDAQ-NMS:RLMD |
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