Virtual event on Tuesday, May 3rd at 10:00 AM ET
An overview of unmet medical needs and therapeutic opportunities in schizophrenia and major neuropsychiatric disorders will be discussed
CUPERTINO, Calif., April 26, 2022 — Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH), (“Reviva” or the “Company”), a clinical-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), respiratory and metabolic diseases today announced that it will host a key opinion leader (KOL) webinar on brilaroxazine (RP5063) for schizophrenia and other neuropsychiatric disorders on Tuesday, May 3, 2022 at 10:00am Eastern Time.
The virtual webinar will feature presentations from Key Opinion Leaders (KOL):
- Leslie Citrome, MD (New York Medical College) who will provide a brief introduction on schizophrenia and major neuropsychiatric disorders with overlapping conditions that are treated with an antipsychotic drug and unmet medical needs
- Larry Ereshefsky, PharmD (Apex Innovative Sciences) who will discuss the pathobiology of schizophrenia, clinical pharmacology of approved antipsychotics, unmet needs and opportunities and challenges in clinical development of new antipsychotics
Reviva’s Founder, President and CEO, Dr. Laxminarayan Bhat, will present data supporting the clinical development strategy for the ongoing Phase 3 evaluation of Reviva’s brilaroxazine (RP5063) in schizophrenia. Brilaroxazine is a new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms with the potential to treat schizophrenia and other neuropsychiatric conditions caused by dysfunctional serotonin and dopamine signaling.
A live question and answer session will follow. To register for the event, please click here.
Leslie Citrome, MD, MPH is clinical professor of psychiatry and behavioral sciences at New York Medical College in Valhalla, New York, clinical professor of psychiatry at SUNY Upstate Medical University, and adjunct clinical professor of psychiatry, Icahn School of Medicine at Mount Sinai in New York City, New York. He is a Distinguished Life Fellow of the American Psychiatric Association and a Fellow of the American Society of Clinical Psychopharmacology where he currently serves as President. In addition to his academic positions, he has a private practice in psychiatry in Pomona, New York and is a volunteer consultant to the Assertive Community Treatment team/Mental Health Association of Rockland County. In 2019 he received the New York Medical College Faculty Author Award for “First Authorship Who Published in the Most Open Access Journals (Web of Science),” and in 2018 and 2021 was recognized as the Voluntary Faculty Teacher of the Year, Department of Psychiatry and Behavioral Sciences, New York Medical College/Westchester Medical Center.
Dr. Citrome obtained his MD degree from the McGill University Faculty of Medicine in 1983 and his MPH degree from the Columbia School of Public Health in 1996. His immediate prior position was as the founding Director of the Clinical Research and Evaluation Facility at the Nathan S. Kline Institute for Psychiatric Research in Orangeburg, New York, where he worked from 1994 through 2010 and achieved the rank of Professor of Psychiatry at the New York University School of Medicine.
Dr. Citrome is currently a consultant in clinical trial design and interpretation. He is a frequent lecturer on the quantitative assessment of clinical trial results, including the metrics of number needed to treat and number needed to harm, and has lectured throughout the Americas, Europe, Asia, and Australasia. His main interests include schizophrenia, bipolar disorder, and major depressive disorder. He is author or coauthor of over 575 research reports, reviews, and chapters in the scientific literature. He is a member of the Board of Directors of the World Association of Medical Editors. Dr. Citrome is editor emeritus, International Journal of Clinical Practice where he was editor-in-chief 2013-2019; psychiatry topic editor for Clinical Therapeutics; editor for the American Society of Clinical Psychopharmacology Corner in the Journal of Clinical Psychiatry; section editor for psychopharmacology for Current Psychiatry; and also serves as an editorial board member for CNS Spectrums, Expert Review of Neurotherapeutics, Neurology and Therapy, Clinical Psychopharmacology and Neuroscience, Annals of Clinical Psychiatry, Expert Opinion on Drug Safety, Current Drug Safety, Schizophrenia Research and Treatment, Postgraduate Medicine, Journal of Clinical Psychopharmacology, Clinical Practice, Medscape Psychiatry & Mental Health.
Larry Ereshefsky PharmD, BCPP, FCCP over his 40 years’ career applies his experience as a clinician, scientist and investigator, to develop treatments and innovate clinical methodologies to make a difference in the lives of patients with Neurodegenerative and Psychiatric Disorders. He has contributed significantly to several drug approvals spanning neurology and psychiatry, including drug development planning, PK/PD evaluation, and methodological innovation for Schizophrenia, Depression, Bipolar Disorder, Parkinson’s (PD), Alzheimer’s Diseases (AD), and pain indications. He has designed, implemented, supervised, and conducted more than 100 CNS clinical trials ranging from first into patient through to proof of concept, implements Asian Bridging strategies, and has overseen large global Phase III registration trials. He is a leader in the use of signal detection strategies to minimize placebo response and insuring study designs preserve statistical power while preserving the blinding. Larry has a proven track record as an investigator, translational CNS scientist, and clinical advisor in designing and performing Phase I/IIA and clinical pharmacology studies.
He is a retired Regents Professor of Pharmacy, Psychiatry, and Pharmacology from The University of Texas/UT Health Science Center (UT). Subsequently, he was the CSO (Chief Scientific Officer) and Exec VP for California Clinical Trials, acquired by PAREXEL International where his role was VP, Principal Pharmacologist and Therapeutic Area Leader for CNS Early Phase with Global responsibilities. Currently, he is the owner of Follow the Molecule: CNS Consulting, providing services to pharma, CROs, technology vendors, and minority owner in ProScience Research Group. He serves as Chief Science Officer for APEX Innovative Sciences (and minority owner) including their 2 x 80 bed early phase research units (CNS Network, CA and Hassman Research Institute, NJ).
As a leader in the application of translational drug development tools including neurocircuitry/biomarker based (RDoC) strategies, i.e., continuous CSF sampling, QEEG, ERP, PSG, sMRI, fMRI, MRS, PET, pain models including capsaicin, UV burn, NGF, allodynia evaluations, and cognitive and behavioral paradigms, he helps de-risk drug development. As co-head of The Advanced Pharmacology and Evaluation Lab at UT, his team made pioneering contributions to understand the relationship of pharmacogenetics, drug interactions, and the environment upon the PK/PD of drugs. Dr. Ereshefsky’s unique perspective as a clinical scientist (clinical psychiatric pharmacist and psychopharmacologist) helps to guide drug development from preclinical to late Phase. He served twice on the FDA Psychopharmacological Drugs Advisory Committee. His PharmD and Residency in Psychopharmacology and Clinical Pharmacy were at the University of Southern California and LA County Medical Center and is Board Certified in Clinical Psychopharmacy.
About Reviva Pharmaceuticals Holdings, Inc.
Reviva is a clinical-stage biopharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing unmet medical needs and burdens to society, patients, and their families. Reviva’s current pipeline focuses on the central nervous system, respiratory and metabolic diseases. Reviva’s pipeline currently includes two drug candidates, RP5063 (brilaroxazine) and RP1208. Both are new chemical entities discovered in-house. Reviva has been granted composition of matter patents for both RP5063 and RP1208 in the United States (U.S.), Europe, and several other countries.
Forward Looking Statements
This press release contains certain 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 and the Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines and expenses, market opportunity, ability to raise sufficient funding, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.
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Reviva Pharmaceuticals Holdings, Inc.
Laxminarayan Bhat, PhD
Investor Relations Contact:
LifeSci Advisors, LLC