CUPERTINO, Calif. — Reviva Pharmaceuticals Holdings, Inc. (NASDAQ:RVPH), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that it will host a key opinion leader (KOL) event on Thursday, February 15, 2024 at 12:00 PM ET, featuring Larry Ereshefsky, PharmD, BCPP (Retired professor of Psychiatry, Pharmacology and Psychiatry, The University of Texas; Chief Scientific Officer, Owner, Follow the Molecule LLC) and Mark Opler, PhD, MPH (Chief Research Officer at WCG Inc., Executive Director of the PANSS Institute), who will discuss the unmet medical need and current treatment landscape for patients suffering from acute to chronic symptoms of schizophrenia, and brilaroxazine (RP5063), a next-generation serotonin/dopamine modulator, as a potential treatment.
The event will focus on reviewing Reviva’s positive topline results and successful completion of pivotal Phase 3 RECOVER trial evaluating the efficacy, safety, and tolerability of once-daily brilaroxazine in adults with acute schizophrenia, as well as the Company’s ongoing enrollment in the one-year open label extension (OLE) trial and the initiation of registrational Phase 3 RECOVER-2 trial.
A live question and answer session will follow the formal presentations.
About Larry Ereshefsky, PharmD, BCPP, FCCP
Larry Ereshefsky, PharmD, BCPP, FCCP, over his 45 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 assisted in the design, 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. 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. 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 also served as Chief Science Officer for APEX Innovative Sciences (minority owner) including their 2 x 80 bed early phase research units (CNS Network, CA and Hassman Research Institute, NJ). APEX was recently bought by CenExel Research providing 18 clinical research sites designing, conducting, and supporting drug development from the earliest (FIH) to late-stage drug development across a variety of indications.
As a leader in the application of translational drug development tools (including measuring neurocircuitry/biomarker/inflammatory signal via MRS, fMRI, electrophysiology, PET, CSF and PBMCs, 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 Psychiatric Pharmacy.
About Mark Opler, PhD, MPH
Mark Opler, PhD, MPH holds the titles of Chief Research Officer at WCG Inc. and Executive Director of the PANSS Institute.
Dr. Opler has served as a faculty member in the Departments of Psychiatry and Environmental Medicine at New York University School of Medicine and in the Department of Neuroscience at Columbia University, College of Physicians and Surgeons. His academic research focuses on the etiology, phenomenology, and treatment of serious and persistent mental disorders. He is a co-author and developer of several clinical assessment tools, including the SNAPSI, CGI-DS, and NY-AACENT. He is a contributor to the latest edition of the PANSS Manual©.
Dr. Opler has received research support from the US NIMH, the Brain & Behavior Foundation (formerly NARSAD), the Stanley Medical Research Institute, and the Qatar National Research Fund. He has co-authored more than 50 peer-reviewed publications and has contributed to multiple book chapters and review articles on clinical assessment, research methodology, and mental health.
He received his PhD and MPH from Columbia University and his BSc from SUNY at Stony Brook. He is a graduate of the Psychiatric Epidemiology Training Program at Columbia University and completed his postdoctoral fellowship at the New York State Psychiatric Institute.
About Brilaroxazine
Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms. Positive topline data from the global Phase 3 RECOVER trial in schizophrenia demonstrated the trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains at week 4 with 50 mg of brilaroxazine vs. placebo with a generally well-tolerated side effect profile comparable to placebo and discontinuation rates lower than placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitor. Reviva believes that a full battery of regulatory compliant toxicology and safety pharmacology studies has been completed for brilaroxazine. Reviva intends to develop brilaroxazine for other neuropsychiatric indications including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD).
Additionally, brilaroxazine has shown promising nonclinical activity for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the U.S. FDA for the treatment of PAH and IPF conditions.
About Reviva
Reviva is a late-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, brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered in-house. Reviva has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries.
Corporate Contact:
Reviva Pharmaceuticals Holdings, Inc.
Laxminarayan Bhat, PhD
www.revivapharma.com
Investor Relations Contact:
LifeSci Advisors, LLC
Bruce Mackle
[email protected]
Media Contact:
Kristin Politi
[email protected]
(646) 876-4783