Early this morning, Relmada Therapeutics Inc. (RLMD:NASDAQ), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, reported top-line data from REL-1017-202, a double-blind, placebo-controlled Phase 2 clinical study evaluating the safety, tolerability and efficacy of two doses of REL-1017 (dextromethadone), 25 mg once a day and 50 mg once a day, as an adjunctive treatment in patients with treatment resistant depression.
The firm reported that the Phase 2 study measured 62 adult subjects with major depressive disorder (MDD) who did not respond to one to three courses of antidepressant treatment in their current episode. The key findings of the trial were that "subjects in both the REL-1017 25 mg and 50 mg treatment groups experienced statistically significant improvement of their depression compared to subjects in the placebo group on all efficacy measures, including: the Montgomery-Asberg Depression Rating Scale (MADRS); the Clinical Global Impression-Severity (CGI-S) scale; the Clinical Global Impression-Improvement (CGI-I) scale; and the Symptoms of Depression Questionnaire (SDQ)." The company advised that the study also confirmed the favorable safety and tolerability profile of REL-1017 as was also observed in the Phase 1 studies.
Dr. Ottavio Vitolo, Relmada's head of R&D and chief medical officer, commented, "We are very pleased to announce these highly compelling results...This is the first clinical evidence that REL-1017 exerts a rapid and robust antidepressant effect, which continues even after treatment discontinuation. These findings replicate what was previously observed in animal studies and support a potentially neurotrophic effect of REL-1017. We would like to thank the participating investigators, our collaborators at Syneos Health and our colleagues at the Massachusetts General Hospital (MGH) Clinical Trials Network and Institute, whose contribution was critical to controlling the placebo response. We look forward to continuing the development of REL-1017 with the goal of bringing a new effective treatment to the millions of patients suffering from depression."
Regarding the study, Maurizio Fava, M.D., chief of the Department of Psychiatry, Massachusetts General Hospital, added, "The results of this Phase 2 study demonstrate a solid and rapid antidepressant effect and overall favorable tolerability and safety profile of REL-1017...Ultimately, the goal is to improve the lives of individuals with serious depression who have not responded to standard therapies. These data suggest that REL-1017 could offer a treatment option to such patients, and I am hopeful that the results of ongoing studies will continue to show great promise."
Relmada's CEO Sergio Traversa also noted, "We are delighted to report these data that we believe represent a critical step forward in the effort to bring a new and potentially treatment paradigm changing option to patients who suffer from major depression...These results confirm for the first time in severely depressed patients that REL-1017 is showing rapid, statistically and clinically meaningful antidepressant activity, in conjunction with a favorable tolerability and safety profile, and a simple oral administration regime. We look forward to discussing with the U.S. Food and Drug Administration the next steps to enable us to rapidly advance the clinical development of this important clinical program."
The company explains in the report that it is developing dextromethadone (REL 1017) as a rapidly acting oral agent for the treatment of depression, and that dextromethadone works as an NMDA receptor antagonist and on the same binding site as ketamine, but has shown no ketamine psychotomimetics side effects. The firm further claims that dextromethadone is fundamentally differentiated from all currently FDA-approved antidepressants, as well as all atypical antipsychotics used adjunctively. The firm indicated that the U.S. FDA granted Fast Track designation for dextromethadone for the adjunctive treatment of major depressive disorder in April 2017.
Relmada Therapeutics states that it is a clinical-stage, biotechnology company "developing novel medicines that potentially address areas of high unmet medical need" in the treatment of depression, central nervous system (CNS) diseases and ophthalmological disorders. The company's diversified portfolio of products at various stages of development include its lead program, dextromethadone (REL-1017), an N-methyl-D-aspartate (NMDA) receptor antagonist as a rapid-acting oral treatment for depression. The firm advises that NMDA receptor antagonists may have potential in the treatment of a range of psychiatric and neurological disorders associated with a variety of cognitive, neurological and behavioral symptoms.
Relmada Therapeutics began the day with a market capitalization of about $110.8 million with approximately 9.894 million shares outstanding. RLMD shares opened much higher today at $32.10 (+$20.9048, +186.733%) over yesterday's $11.1952 closing price. The stock has traded wildly today between $18.67 and $36.00/share and closed at $26.20 (+$15.00, +134.03%).[NLINSERT]
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