Full Press Release Details
Therapeutics Expands R&D Team, Appoints Paolo Manfredi, M.D., as Acting Chief Scientific Officer,
Marco Pappagallo, M.D., as
Acting Chief Medical Officer and Updates R&D Milestones
New York, October, 27, 2020 (PR Newswire) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a clinical-stage company developing
novel therapies for the treatment of central nervous system (CNS) diseases, today announced the expansion of its leadership team
with the appointments of Paolo Manfredi, M.D., as Acting Chief Scientific Officer and Marco Pappagallo, M.D., as Acting Chief
Medical Officer. The Company also provided an update of upcoming milestones for the REL-1017 program.
Dr. Manfredi has been the co-founder of Medeor,
Inc. (now merged into Relmada), for which he also served as Scientific Director and co-inventor of REL-1017. Prior to this,
Dr. Manfredi was an Assistant Professor in Neurology and Neuroscience at the Weill Medical College of Cornell University and served
as the Fellowship Director of the Pain and Palliative Care Program at Memorial Sloan Kettering Cancer Center. Dr. Manfredi earned
his Doctor of Medicine at the University of Genoa, Italy, completed his residency in neurology at Albert Einstein College of Medicine
and completed several postdoctoral training fellowships, including a pain management fellowship at Massachusetts General Hospital
and Harvard University.
Dr. Pappagallo most recently served as Chief
Medical Officer at CerSci Therapeutics, a privately-held biotech company focused on developing pain therapeutics that was recently
acquired by ACADIA Pharmaceuticals. Prior to this, he held the role of Medical Expert-in-Residence and Executive Director of Medical
Intelligence at Gr nenthal - USA. Dr. Pappagallo previously served as the co-founder and Chief Medical Officer of NovaPharm
Therapeutics. Dr. Pappagallo served in a number of senior roles at leading medical institutions, including as the Director of Chronic
Pain in the Department of Pain and Palliative Care at Beth Israel Medical Center and Professor and Director of Pain Research in
the Department of Anesthesiology at Mount Sinai Medical Center. Dr. Pappagallo completed his medical school and post-graduate
training in neurosurgery at the University of Rome, Italy. Subsequently, he completed his neurology residency training at the State
University of New York at Stony Brook and was a clinical and research fellow in pain medicine at John Hopkins University.
Relmada also provided an R&D milestone
update, as the company continues to be on track to start its first pivotal Phase III trial of REL-1017 for the adjunctive treatment
of major depressive disorder (MDD) in the fourth quarter of 2020. Also, this quarter, the company expects to begin its human
abuse potential studies of REL-1017. Other anticipated milestones for REL-1017 in 2021 include:
"We are delighted to welcome Dr. Manfredi
and Dr. Pappagallo to Relmada' s leadership team. Dr. Manfredi was the co-founder of Medeor, Inc., now merged into Relmada.
As a co-inventor of our core technology, Dr. Manfredi's deep insight and expertise will continue to be invaluable in the
further clinical development of our lead product candidate, REL-1017," said Sergio Traversa, Chief Executive Officer of Relmada.
"Dr. Pappagallo brings over 30 years of medical expertise in neurology medicine. With his significant experience directing
clinical programs and passion for addressing significant medical unmet needs, Dr. Pappagallo will be instrumental in shaping Relmada'
s future clinical development strategy and execution. We look forward to the significant contributions of both of these world-renowned
medical experts. We are also quite excited to provide our milestone update, which highlights our team's robust progress,
as we continue to advance REL-1017's late-stage development."
"I am delighted to expand my commitment
to Relmada to oversee its research programs as Acting Chief Scientific Officer and lead the scientific development of REL-1017,
a compound with which I am extremely familiar and I look forward to advancing this innovative treatment," said Dr. Manfredi.
Dr. Pappagallo commented, "I am excited
about joining a team focused on addressing diseases of the CNS with innovative approaches, and most importantly to help the millions
people who continue to need new options for the treatment of MDD. I look forward to leading the next and last phase of clinical
development of REL-1017, as an adjunctive as well as front line monotherapy treatment of MDD, as we progress our development program."
REL-1017, a novel NMDA receptor (NMDAR) channel
blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is entering
late-stage studies as an adjunctive treatment for MDD in adults. In addition to safety and efficacy, our clinical program
for REL-1017 will evaluate its potential as the first rapid-acting, oral, once-daily antidepressant treatment. In a Phase
2 trial, REL-1017 demonstrated rapid onset and sustained antidepressant effects with statistically significant improvements as
compared to placebo on efficacy measures. The Phase 2 study also confirmed the favorable safety and tolerability profile
of REL-1017 observed in previously completed Phase 1 studies. In April 2017, the FDA granted Fast Track designation for REL-1017
for the adjunctive treatment of major depressive disorder.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a late-stage pharmaceutical
company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). Our experienced
and dedicated team is committed to making a difference in the lives of patients and their families. Relmada' s lead
program, REL-1017, is a novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining
physiological glutamatergic neurotransmission, and is entering late-stage studies as an adjunctive treatment for MDD in adults.
Forward-Looking Statements
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which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section
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