Relmada Therapeutics Announces Notice of Acceptance of Key Patent in Europe Covering NMDA Receptor Antagonist d-Methadone for Treatment of Psychiatric Symptoms

NEW YORK, Jan. 9, 2018 /PRNewswire/ -- Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, announced today that the European Patent Office has issued a notice of allowance for patent application number 13773543.7 for "D-methadone for the treatment of psychiatric symptoms." The patent provides broad coverage in Europe for d-Methadone (dextromethadone, REL-1017), a novel N-methyl-D-aspartate (NMDA) receptor antagonist, for the treatment of symptoms associated with a range of psychological and psychiatric disorders including depression, anxiety, fatigue and mood instability.

"The allowance of this key patent significantly strengthens our IP position and the global commercial opportunities in our d-Methadone program," said Sergio Traversa, CEO of Relmada Therapeutics. "We look forward to advancing our current development programs and to working to identify potential new areas of unmet need where d-Methadone can deliver benefits to patients in the years ahead."

The NMDA receptor is a predominant molecular device for controlling synaptic plasticity and memory function and affects the transfer of electrical signals between neurons in the brain and in the spinal column. Based on their mechanism of action, a range of NMDA receptor antagonists (chemicals that deactivate the NMDA receptor) such as d-Methadone are under consideration as potential therapeutic agents for the treatment of many CNS conditions including some psychiatric disorders.    

In April 2017, Relmada announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for d-Methadone for the adjunctive treatment of major depressive disorder. The company plans to advance the development program for d-Methadone to a Phase 2a randomized, double-blind, placebo-controlled study. This trial will assess changes in depressive symptoms as well as the safety, tolerability and pharmacokinetics of two dose levels of REL-1017 as a rapid-acting adjunctive treatment in patients affected by major depression.

About dextromethadone (d-Methadone, REL-1017)

Relmada's dextromethadone is being developed as a rapidly acting oral agent for the treatment of depression with the potential to treat an array of additional neurologic disorders. Working through the same brain mechanisms as ketamine, a non-competitive NMDA channel antagonist, but potentially lacking its adverse 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, d-Methadone (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.

Contact

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SOURCE Relmada Therapeutics, Inc.