Reviva Announces New Vocal Biomarker Data from Phase 3 RECOVER Trial of Brilaroxazine in Schizophrenia

Rhea-AI Summary

Reviva Pharmaceuticals Holdings (NASDAQ: RVPH) has announced new vocal biomarker data from its Phase 3 RECOVER trial of brilaroxazine in schizophrenia. The data, presented during a virtual key opinion leader event, showed statistically significant speech latency results, reinforcing the drug's strong efficacy for negative symptoms and other key symptom domains of schizophrenia.

Highlights include:

• Brilaroxazine demonstrated a safety profile comparable to placebo
• Strong efficacy across major symptom domains, including negative symptoms
• Vocal biomarker data provides an objective tool supporting primary and secondary endpoints
• Additional data from an ongoing open-label extension study expected in Q4 2024

Experts emphasized brilaroxazine's potential to address unmet needs in schizophrenia treatment, particularly its efficacy for negative symptoms and cognition, coupled with a strong efficacy-to-side-effect ratio.

Positive

• Statistically significant vocal biomarker speech latency data reinforces brilaroxazine's efficacy for schizophrenia symptoms
• Brilaroxazine demonstrated a safety profile comparable to placebo
• Strong efficacy across major symptom domains, including negative symptoms
• Potential to address unmet needs in schizophrenia treatment, particularly negative symptoms and cognition
• Strong efficacy-to-side-effect ratio reported

Negative

• None.

Medical Research Analyst

The new vocal biomarker data from Reviva's Phase 3 RECOVER trial for brilaroxazine in schizophrenia is highly significant. Speech latency, an objective measure, statistically validates the drug's efficacy across multiple symptom domains, including the challenging negative symptoms. This objective data strengthens the credibility of the previously reported positive results.

The drug's efficacy in addressing negative symptoms is particularly noteworthy, as this remains an unmet need in schizophrenia treatment. If approved, brilaroxazine could potentially fill a critical gap in the current treatment landscape. The reported safety profile, comparable to placebo, is also promising, as it could lead to improved patient adherence.

Investors should closely monitor the upcoming Q4 2024 data from the open-label extension study, which could further solidify brilaroxazine's potential market position.

Financial Analyst

Reviva Pharmaceuticals' announcement is potentially transformative for the company's market position. The positive vocal biomarker data reinforces the efficacy of brilaroxazine, potentially increasing its chances of FDA approval and subsequent market success.

If approved, brilaroxazine could capture a significant market share in the schizophrenia treatment space, estimated to reach $9.48 billion by 2026. The drug's efficacy across multiple symptom domains, especially negative symptoms, could lead to premium pricing and rapid adoption.

However, investors should note that Reviva is still a pre-revenue company. The path to commercialization involves regulatory hurdles and potential competition. The Q4 2024 data will be important in determining the long-term value proposition of brilaroxazine and Reviva's stock.

Psychiatry Expert

The vocal biomarker data for brilaroxazine is groundbreaking in schizophrenia research. Speech latency as an objective measure adds a new dimension to assessing drug efficacy, potentially revolutionizing clinical trials in psychiatry.

Brilaroxazine's efficacy across multiple symptom domains, especially negative symptoms, addresses a critical unmet need. Current antipsychotics often fall short in treating negative symptoms, which significantly impact patients' quality of life and social functioning.

The reported safety profile, comparable to placebo, is exceptional for an antipsychotic. If maintained in larger populations, this could lead to improved treatment adherence, a major challenge in schizophrenia management. However, long-term safety data from the open-label extension study will be important to confirm these promising initial results.

– Statistically significant vocal biomarker speech latency data reinforce the strong efficacy of brilaroxazine for negative symptoms and other key symptom domains of schizophrenia –

– Additional vocal biomarker data from ongoing open label extension study evaluating brilaroxazine in schizophrenia expected Q4 2024 –

CUPERTINO, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), 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 announces new vocal biomarker data from Phase 3 RECOVER trial of brilaroxazine in schizophrenia was presented during a virtual key opinion leader event hosted by the Company on September 4, 2024 featuring Brian Kirkpatrick, MD, MSPH (Professor, Psychiatric Research Institute, University of Arkansas for Medical Sciences, Arkansas) and Mark Opler, PhD, MPH (Chief Research Officer at WCG Inc., Executive Director of the PANSS Institute, New York). A replay of the event can be found at https://revivapharma.com/events/.

“Brilaroxazine has demonstrated a safety profile comparable to placebo, with broad spectrum efficacy across the major symptom domains of schizophrenia, including negative symptoms,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “These new vocal biomarker data provide an objective tool that further supports the primary and secondary endpoints evaluated in the RECOVER trial. We look forward to further evaluating vocal biomarker data from patients in our ongoing open label extension study with topline data expected in the fourth quarter of the year.”

Dr. Brian Kirkpatrick, Professor, Psychiatric Research Institute, University of Arkansas for Medical Sciences added, “The results using this objective, automated vocal biomarker confirms robust treatment effects on total, positive, and negative symptoms, social function, disorganization and overall efficacy following treatment with brilaroxazine. These findings are consistent with previous assessments and add to the clinical data supporting a strong treatment effect across domains with brilaroxazine.”

Key highlights of the vocal biomarker data include:

• Speech latency is an emerging objective vocal biomarker that can help validate scale-based assessments completed by human raters
• Brilaroxazine demonstrated a strong efficacy for negative symptoms and other key symptoms of schizophrenia such as total and positive symptoms, disorganization, and social functioning in the pivotal phase 3 RECOVER trial in schizophrenia
• Statistically significant results of the vocal biomarker speech latency data analysis from the RECOVER trial further support the strong efficacy of brilaroxazine for negative symptoms and other key symptom domains of schizophrenia
  

Dr. Mark Opler, Chief Research Officer at WCG Inc. and Executive Director of the PANSS Institute, New York added, “Current marketed therapies do not address critical aspects of schizophrenia such as negative symptoms and cognition. In addition to suboptimal efficacy, the poor tolerability of current antipsychotics also contributes to low treatment adherence and high discontinuation rates across patients. The consistent, widespread efficacy of brilaroxazine across multiple domains, coupled with the very strong efficacy-to-side-effect ratio, supports the potential of brilaroxazine to significantly address unmet needs in the treatment of schizophrenia.”

About Brilaroxazine
Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in the pathophysiology of several conditions including schizophrenia, psoriasis and interstitial lung diseases like pulmonary hypertension, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF).

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 including reduction in key proinflammatory cytokines implicated in the pathophysiology of schizophrenia and comorbid inflammatory conditions 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 the CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitors. 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. To learn more about the clinical and preclinical data available for brilaroxazine, please visit revivapharma.com/publications.

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 (CNS), inflammatory and cardiometabolic 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.

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 1-year open label extension (OLE) trial evaluating the long-term safety and tolerability for brilaroxazine in schizophrenia, the registrational Phase 3 RECOVER-2 trial, the Company’s expectations regarding the anticipated clinical profile of its product candidates, including statements regarding anticipated efficacy or safety profile, and those relating to the Company’s expectations, intentions or beliefs regarding matters including product development and clinical trial plans, clinical and regulatory timelines and expenses, planned or intended additional trials or studies and the timing thereof, planned or intended regulatory submissions and the timing thereof, trial results, market opportunity, ability to raise sufficient funding, competitive position, possible or assumed future results of operations, business strategies, potential opportunities for development including partnerships, growth or expansion 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.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and the Company’s other filings from time to time with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes 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, LLC
Bruce Mackle
bmackle@lifesciadvisors.com 

FAQ

What were the key findings of Reviva's Phase 3 RECOVER trial for brilaroxazine (RVPH)?

The Phase 3 RECOVER trial of brilaroxazine (RVPH) showed statistically significant vocal biomarker speech latency data, reinforcing the drug's strong efficacy for negative symptoms and other key symptom domains of schizophrenia. The drug demonstrated a safety profile comparable to placebo and showed strong efficacy across major symptom domains.

When will Reviva (RVPH) release additional vocal biomarker data for brilaroxazine?

Reviva (RVPH) expects to release additional vocal biomarker data from the ongoing open-label extension study evaluating brilaroxazine in schizophrenia in the fourth quarter of 2024.

How does brilaroxazine (RVPH) differ from current schizophrenia treatments?

Brilaroxazine (RVPH) shows potential to address unmet needs in schizophrenia treatment, particularly its efficacy for negative symptoms and cognition, which are not adequately addressed by current therapies. It also demonstrates a strong efficacy-to-side-effect ratio, which could improve treatment adherence compared to existing antipsychotics.

What is the significance of the vocal biomarker data in Reviva's (RVPH) Phase 3 RECOVER trial?

The vocal biomarker data provides an objective tool that supports the primary and secondary endpoints evaluated in the RECOVER trial. Speech latency, an emerging objective vocal biomarker, helps validate scale-based assessments completed by human raters, adding credibility to the efficacy results of brilaroxazine.