Full Press Release Details
Relmada Therapeutics
Acquires Global Rights to Develop and Market Dextromethadone for Treatment of Disorders of the Nervous System
Agreement positions company to advance dextromethadone
program to its full potential targeting a wide range of neurological conditions including certain rare genetic diseases
NEW YORK, NY, January 17, 2018 - 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
"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)
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,
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
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SOURCE Relmada Therapeutics, Inc.