Reviva Pharmaceuticals Holdings, Inc. Receives Letter from FDA for Pivotal Phase 3 Clinical Trial and Long-Term Safety Trial Evaluating Brilaroxazine for the Treatment of Schizophrenia


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– Brilaroxazine is a new modulator of serotonin and dopamine receptors under development for diseases with dysfunctional serotonergic signaling, including neuropsychiatric and pulmonary indications –

The launch of the two phase 3 trials is expected by the end of January 2022 –

CUPERTINO, Calif., Jan. 10, 2022 (GLOBE NEWSWIRE) – Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH), a clinical-stage pharmaceutical company developing therapies to address unmet medical needs in areas of the central nervous system (CNS), cardiovascular, metabolic and inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has informed the Company that it may conduct a Phase 3 clinical study of its lead candidate, brilaroxazine, a new modulator of serotonin and dopamine receptors for the treatment of schizophrenia.

“We believe the FDA clearance to initiate a pivotal Phase 3 trial, along with an additional Phase 3 trial focused on long-term safety, represents a transformative step that can support the filing and approval of a new drug application for our lead candidate brilaroxazine in patients with schizophrenia. The two Phase 3 trials will be launched simultaneously, with the long-term safety study designed to complement the efficacy and safety data from the pivotal trial, ”said Laxminarayan Bhat, Ph.D., founder , President and CEO of Reviva. “Collectively, these two trials may provide a robust Phase 3 evaluation of brilaroxazine in patients with schizophrenia that we believe will complement our successful Phase 2 study. We remain strongly encouraged by the therapeutic potential of brilaroxazine and look forward to launching the two Phase 3 trials by the end of January 2022. “

Schizophrenia is a complex and debilitating neuropsychiatric disorder that affects approximately 1% of the world’s population and approximately 3.5 million people in the United States alone. Characterized by multiple symptoms, patients with schizophrenia often suffer from cognitive impairment, delusions, hallucinations, and disorganized speech or behavior. Despite its high prevalence, there are no therapies that adequately address the complex mix of positive and negative symptoms, mood, and cognitive impairment associated with schizophrenia. Limitations of current treatments include suboptimal efficacy, poor tolerability, and low patient adherence rates.

About brilaroxazine (RP5063)Brilaroxazine (RP5063) is a new chemical entity with potent affinity and selectivity against the major serotonin and dopamine receptors involved in schizophrenia and its co-morbid symptoms. In a multinational, multicenter, double-blind, Phase 2 study of 234 patients with acute schizophrenia or schizoaffective disorder, brilaroxazine met its primary endpoint, reducing the total score on the scale. positive and negative syndrome (PANSS) and demonstrating statistically significant improvements in secondary endpoints assessing social functioning, and positive and negative symptoms. A comprehensive battery of regulatory toxicological and pharmacological safety studies has been performed for brilaroxazine. In this completed Phase 2 study, brilaroxazine met all criteria for safety with no weight gain, no increase in blood sugar and lipids, and no cardiac or endocrine adverse reactions compared to placebo. The United States Food and Drug Administration (FDA) has agreed to consider a possible “superior safety” claim if there is a positive result on a relevant endpoint in a pivotal Phase 3 study in patients with schizophrenia. Additionally, the Company believes that brilaroxazine has the potential to delay disease progression in PAH and IPF. Brilaroxazine has previously received orphan drug designation by the US FDA for the treatment of these conditions. To learn more about the clinical and preclinical data available for brilaroxazine, please visit revivapharma.com/publications.

About RevivaReviva is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize next-generation therapies for diseases presenting unmet medical needs and burdens on 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 internally. Reviva has obtained composition of matter patents for RP5063 and RP1208 in the United States (United States), Europe and several other countries.

Forward-looking statementsThis 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 product development of the Company. , clinical and regulatory times and expenses, market opportunities, ability to raise sufficient funds, competitive position, possible or expected future operating results, business strategies, potential growth opportunities and other statements predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections regarding the industry and markets in which we operate and on the current beliefs and assumptions of management.

These statements can be identified by the use of forward-looking phrases, including, but not limited to, “expect”, “anticipate”, “intend”, “plan“, “believe” , “Estimate”, “,” “project”, “should”, “would” and similar expressions and negatives of these terms. These statements relate to future events or to our financial performance and involve known and unknown risks , uncertainties and other factors that may cause actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by the future. documents filed by the Company with the Securities and Exchange Commission.Potential investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company assumes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Corporate contact:Reviva Pharmaceuticals Holdings, Inc.Laxminarayan Bhat, PhD www.revivapharma.com

Investor Relations Contact:LifeSci Advisors, LLCBruce Macklebmackle@lifesciadvisors.com

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Source: Reviva Pharmaceuticals

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