Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, announced today that it has acquired the global rights to develop and market dextromethadone (REL-1017), a novel N-methyl-D-aspartate (NMDA) receptor antagonist, for the treatment of neurological conditions including certain rare diseases with symptoms affecting the CNS.
The company expects to select and initiate development for additional indications in 2018. Relmada previously acquired the global rights to dextromethadone for the treatment of symptoms associated with a range of psychological and psychiatric disorders including depression, anxiety, fatigue, and mood instability and plans to start to enroll patients in a Phase 2a randomized, double-blind, placebo-controlled study of two dose levels of dextromethadone as a rapid acting adjunctive treatment in patients affected by major depression in the first half of 2018.
"The clinically proven mechanism of action of dextromethadone shows potential benefits in the treatment of a wide range of CNS diseases and conditions, including rare diseases that represent significant areas of unmet need in healthcare," said Sergio Traversa, CEO of Relmada Therapeutics. "We believe that this new agreement is the most important transaction for Relmada since its inception, positioning us to target a wide range of development and global marketing opportunities for dextromethadone in the years ahead."
The NMDA receptor is a therapeutic drug target for many CNS disorders and is a predominant molecular device for controlling synaptic plasticity and memory function, allowing for the transfer of electro-chemical signals between neurons. Based on this clinically proven mechanism of action, several NMDA receptor antagonists (chemicals that block overactive NMDA receptor), including dextromethadone are considered as therapeutic agents for CNS disorders.
In April 2017, Relmada announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for dextromethadone for the adjunctive treatment of major depressive disorder. The company plans to advance the development program of dextromethadone to a Phase 2a randomized, double-blind, placebo-controlled study that will assess changes in depressive symptoms as well as the safety, tolerability and pharmacokinetics of two dose levels of dextromethadone as a rapid acting adjunctive treatment in patients affected by major depression. The company has also initiated a pre-clinical program to identify the most appropriate additional neurological indications for dextromethadone, including certain rare syndromes affecting the CNS.
About dextromethadone (REL 1017)
Relmada is currently developing dextromethadone as a rapidly acting oral agent for the treatment of depression. 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. With today's agreement we can expand the development to an array of additional neurologic disorders including certain rare diseases characterized by symptoms affecting the Central Nervous System.
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.
