The Conversation (0)
- Dr. Quirk brings more than 20 years of neuroscience drug discovery and development experience to lead Relmada's sepranolone program, building on his tenure as Chief Scientific Officer at Sage Therapeutics.
Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today announced the appointment of Michael Quirk, PhD, as Senior Advisor Sepranolone Program. Dr. Quirk's deep expertise in CNS translational science, neuroactive steroid biology, and clinical development will be instrumental in advancing sepranolone, Relmada's GABAA receptor modulator program targeting Prader-Willi Syndrome and other CNS indications.
"We are very pleased to welcome Mike to the Relmada team. His distinguished career in CNS drug discovery and development, including his leadership of research and scientific strategy at Sage Therapeutics, gives him a unique and highly relevant perspective on neuroactive steroid biology that we believe will be invaluable to the sepranolone program," said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics.
"Sepranolone's mechanism of action – selectively antagonizing the effects of allopregnanolone at GABA-A receptors without broadly disrupting GABAergic signaling – represents a precise and elegant approach to modulating neural circuits that are dysregulated in compulsivity-related disorders like Prader-Willi syndrome," said Dr. Quirk, Senior Advisor – Sepranolone Program. "I believe sepranolone has the potential to be a genuinely differentiated medicine for patients who currently have very limited options. I am excited to join the Relmada team and contribute to advancing this program toward clinical proof-of-concept."
About Michael Quirk, PhD
Michael Quirk is a trained neurophysiologist and translational scientist with 20 years of diverse biopharmaceutical industry experience. Most recently, Mike served as Chief Scientific Officer and interim Head of R&D at Sage Therapeutics (Sage) where he worked on the first medicines approved for the treatment of Postpartum Depression and helped to build a portfolio targeting a range of brain health conditions with a specific interest in indications at the intersection of neuroscience and women's health.
Prior to joining Sage in 2014, Mike was a Director within the Neuroscience Innovative Medicine group at AstraZeneca working on a variety of programs within psychiatry and neurology.
Mike holds both an S.B. degree in Cognitive Science and a Ph.D. in Systems Neuroscience from the Massachusetts Institute of Technology and completed his post-doctoral training at Cold Spring Harbor Laboratory in New York studying neural mechanisms of decision-making and goal-directed behavior.
About Sepranolone and GABA Modulation
Sepranolone, a synthetic isoallopregnanolone, selectively modulates GABAA receptors by antagonizing allopregnanolone (ALLO), without disrupting GABA signaling. It targets disorders linked to excess GABAergic activity such as Prader-Willi syndrome, Tourette syndrome, and obsessive-compulsive disorder (OCD). More than 335 patients have been treated with sepranolone in clinical trials to date, with an excellent safety profile.
About Prader-Willi Syndrome (PWS)
PWS is a rare genetic disorder caused by chromosomal deletions on chromosome 15, leading to neurodevelopmental and behavioral complications. Global prevalence is estimated to be 350,000-400,000 patients. Current treatments address symptoms but do not modify the underlying neurobehavioral pathology.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for oncology and central nervous system conditions. Its lead candidates, NDV-01 and sepranolone, are advancing through mid-stage clinical development with the potential to address significant unmet needs.
For more information, visit 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. This press release contains statements 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. 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 "if", "may", "expects", "anticipates", "believes", "will", "will likely result", "will continue", "plans to", "potential", "promising", and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including potential for Relmada's product candidates to fail to progress, potential for Phase 2 NDV-01 data to fail to continue to deliver positive results supporting further development, potential for clinical trials to fail to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of interim or top-line results to accurately reflect the complete results of the trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to continue to secure FDA agreement on the regulatory path for NDV-01 and/or sepranolone, or that future NDV-01 and/or sepranolone clinical results will be acceptable to the FDA, failure to secure adequate NDV-01 and/or sepranolone drug supply, failure of pending patent applications to result in issued patents, or issued patents being challenged and invalidated by third parties or not providing us with any competitive advantages, the Company's cash runway and sufficiency of the Company's cash resources and uncertainties inherent in estimating the Company's cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials, and the other risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. 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 the risks, uncertainties and other factors that may affect future results and that the risks described herein are not a complete list.
Investor Contact:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com
Media Inquiries:
Corporate Communications
media@relmada.com
