Relmada Therapeutics Allowed Patent Application in China Covering NMDA Receptor Antagonist d-Methadone for Treatment of Psychiatric Symptoms

NEW YORK, Aug. 9, 2018 /PRNewswire/ -- Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced that the State Intellectual Property Office of China has issued a Decision to Grant for Relmada's patent application number 201380061197.3, titled "d-Methadone for the Treatment of Psychiatric Symptoms". The patent that will issue from this allowed application provides broad coverage in China for d-methadone (dextromethadone, REL-1017), a novel once-a-day oral direct inhibitor of activated NMDARs with a substantial safety database and activity on a par with ketamine demonstrated across multiple preclinical models, for the treatment of symptoms associated with a wide range of psychological and psychiatric disorders, including depression, anxiety, fatigue, and mood instability.

"This is the first patent ever granted for d-methadone in China and is a significant milestone as we work to further strengthen our intellectual property portfolio in multiple markets around the world," said Sergio Traversa, CEO of Relmada Therapeutics. "With a population of approximately 1.4 billion people, China represents a significant market opportunity for Relmada. We look forward to reporting top-line data from our ongoing Phase 2a clinical study evaluating the safety and efficacy of REL-1017, as an adjunctive treatment in patients affected by Major Depressive Disorder (MDD) in the first half of 2019."

NMDA receptors (NMDARs) play an important role in several brain functions from synaptic plasticity to memory formation. Abnormal activation of NMDARs has been shown to be involved in depression and other neuropsychiatric conditions. Based on their mechanism of action, a range of NMDAR antagonists (chemicals that reduce the activity of NMDARs), such as dextromethadone, are under development as potential therapeutic agents for the treatment of several CNS conditions including psychiatric and neurological disorders.    

In the second quarter of 2017, the U.S. Food and Drug Administration granted Fast Track designation for d-methadone for the adjunctive treatment of MDD. Relmada initiated a Phase 2, multicenter, randomized, double-blind, placebo-controlled, 3-arm study in the second quarter of 2018 to assess the safety, tolerability and efficacy of two once-daily oral doses of dextromethadone as adjunctive therapy in the treatment of patients with major depressive disorder who have not responded adequately to several antidepressant treatments

About dextromethadone (REL 1017)

Relmada is currently developing dextromethadone as a rapidly acting oral agent for the treatment of depression. Working as an NMDA receptor antagonist and on the same binding site as ketamine but having shown no ketamine psychotomimetics side effects, dextromethadone is fundamentally differentiated from all currently FDA-approved antidepressants, as well as all atypical antipsychotics used adjunctively. 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 that potentially address areas of high unmet medical need in the treatment of central nervous system (CNS) diseases. The Company has a diversified portfolio of products at various stages of development. Relmada's lead program, dextromethadone (REL-1017), is an N-methyl-D-aspartate (NMDA) receptor antagonist. 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. For more information, please visit Relmada's website at www.relmada.com.

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. We may from time to time make written or oral statements in this letter, the proxy statements filed with the SEC communications to stockholders and press releases 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. These forward-looking statements are based upon management's current expectations, estimates, assumptions and beliefs concerning future events and conditions and may discuss, among other things, anticipated future performance, expected product development, product potential, future business plans and costs. 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" and similar expressions. 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 of the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be considered to be a complete list.

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SOURCE Relmada Therapeutics, Inc.