Reviva Announces Grant of U.S. Patent Covering Use of Brilaroxazine for the Treatment of Idiopathic Pulmonary Fibrosis

Rhea-AI Summary

Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) has announced the grant of U.S. Patent 12053477 by the USPTO for the use of brilaroxazine in treating idiopathic pulmonary fibrosis (IPF) and pulmonary fibrosis in patients with COPD, sickle cell anemia, scleroderma, or lung cancer. This patent complements existing protection in Japan. Notably, brilaroxazine has received Orphan Drug Designation from the FDA for IPF treatment.

Dr. Laxminarayan Bhat, CEO of Reviva, emphasized the expansion of their intellectual property portfolio, highlighting brilaroxazine's potential in treating inflammatory conditions related to serotonin signaling disruption. This patent strengthens Reviva's position in developing treatments for interstitial lung diseases.

Positive

• Granted U.S. Patent 12053477 for brilaroxazine in treating IPF and related conditions
• Received Orphan Drug Designation from FDA for brilaroxazine in IPF treatment
• Expanded intellectual property protection in key markets (U.S. and Japan)

Negative

• None.

Insights

Medical Research Analyst

The grant of a U.S. patent for brilaroxazine in treating idiopathic pulmonary fibrosis (IPF) is a significant development for Reviva Pharmaceuticals. This patent, along with the existing one in Japan, strengthens the company's intellectual property portfolio. The Orphan Drug Designation for IPF treatment further enhances brilaroxazine's market potential.

IPF is a rare, progressive lung disease with treatment options. Brilaroxazine's potential to address the underlying serotonin signaling disruption in IPF could offer a novel approach. However, it's important to note that patent approval doesn't guarantee clinical efficacy or regulatory approval. The drug's success will ultimately depend on its performance in clinical trials and FDA review.

Investors should monitor Reviva's progress in advancing brilaroxazine through clinical development for IPF. The expanded IP protection could potentially increase the drug's commercial value if it proves effective in clinical trials.

Financial Analyst

This patent grant is a positive development for Reviva Pharmaceuticals (NASDAQ: RVPH), potentially enhancing its long-term value proposition. The expanded IP protection for brilaroxazine in the U.S. and Japan - two major pharmaceutical markets - could translate into significant commercial opportunities if the drug succeeds in clinical trials and gains regulatory approval.

The Orphan Drug Designation for IPF treatment is particularly noteworthy, as it offers benefits like market exclusivity, tax credits for clinical trials and waiver of FDA application fees. These factors could improve the drug's profitability if approved.

However, investors should remain cautious. Reviva is still a late-stage pharmaceutical company and the path to drug approval and commercialization is long and uncertain. The company's financial health, cash runway and ability to fund further clinical development will be important factors to watch.

CUPERTINO, Calif., Aug. 06, 2024 (GLOBE NEWSWIRE) -- -Similar patent has also been granted in Japan

-Brilaroxazine has received Orphan Drug Designation for the treatment of idiopathic pulmonary fibrosis (IPF)

Cupertino, Calif., August 6, 2024 – 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 announced United States (U.S.) Patent 12053477 has been granted by the U.S. Patent and Trademark Office (USPTO) covering use of brilaroxazine for the treatment of idiopathic pulmonary fibrosis (IPF), and for the treatment of pulmonary fibrosis in a subject having chronic obstructive pulmonary disease (COPD), sickle cell anemia, scleroderma, or lung cancer, adding to its existing patent protection in key market Japan. Brilaroxazine has received Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of IPF.

“We are pleased to further expand our intellectual property (IP) for brilaroxazine which we believe has the broad therapeutic potential to treat inflammatory conditions like IPF driven by underlying disruption in serotonin signaling,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO. “This additional patent builds on our existing IP in pulmonary hypertension and is designed to maximize the value of brilaroxazine for the treatment of interstitial lung diseases.”

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 pathobiology 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-1 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 pathobiology 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 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. 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, clinical and regulatory timelines and expenses, planned or additional studies, planned or potential additional indications for the Company’s product candidates, planned or intended regulatory submissions, 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

Media Contact:
Kristin Politi
kpoliti@lifescicomms.com
(646) 876-4783

FAQ

What is the new U.S. patent granted to Reviva Pharmaceuticals (RVPH) for?

Reviva Pharmaceuticals (RVPH) has been granted U.S. Patent 12053477 for the use of brilaroxazine in treating idiopathic pulmonary fibrosis (IPF) and pulmonary fibrosis in patients with certain conditions like COPD, sickle cell anemia, scleroderma, or lung cancer.

Has brilaroxazine received any special designations from the FDA for RVPH?

Yes, brilaroxazine has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis (IPF).

In which countries does Reviva Pharmaceuticals (RVPH) now have patent protection for brilaroxazine?

Reviva Pharmaceuticals (RVPH) now has patent protection for brilaroxazine in the United States and Japan, as mentioned in the press release.

What potential does Reviva Pharmaceuticals (RVPH) see in brilaroxazine?

Reviva Pharmaceuticals (RVPH) believes brilaroxazine has broad therapeutic potential to treat inflammatory conditions like IPF that are driven by underlying disruption in serotonin signaling.