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]Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.
