Reviva Pharmaceuticals Announces Successful Completion of Pre-IND Meeting with FDA on Brilaroxazine for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)

CUPERTINO, Calif.–(BUSINESS WIRE)–Reviva Pharmaceuticals, Inc. (Reviva), a privately held, clinical stage
pharmaceutical company today announced that it has successfully
completed a pre-Investigational New Drug (IND) Application meeting with
the U.S. Food and Drug Administration (FDA) for its drug candidate
brilaroxazine, which is being developed for the treatment of idiopathic
pulmonary fibrosis (IPF). The FDA has recently granted Orphan Drug
Designation to brilaroxazine for treating patients with IPF.

A pre-IND meeting provides an opportunity for an open communication
between the sponsor and the FDA to discuss the IND development plan and
to obtain the agency’s guidance for clinical studies for the sponsor’s
new drug candidate. The FDA has reviewed brilaroxazine IND enabling
preclinical data, and clinical phase 1 study results and phase 2 study
plan for IPF. The FDA addressed Reviva’s questions and provided guidance
on the brilaroxazine clinical development plan for IPF.

“We are very pleased with the outcome of the pre-IND meeting with the
FDA,” said Laxminarayan Bhat, PhD. Reviva’s Founder, President and Chief
Executive Officer. “We look forward to initiating brilaroxazine phase 2
study for IPF soon.”

About Idiopathic Pulmonary Fibrosis (IPF)

IPF is a progressive, debilitating and fatal lung disease that affects
approximately 3 million people worldwide. IPF is characterized by
inflammation and fibrosis of the lungs, hindering the ability to process
oxygen and causing shortness of breath. Mortality from IPF is increasing
steadily worldwide with a median survival time from diagnosis of 2-5
years. It is estimated that there will be between 28,000 and 65,000
deaths in Europe and between 13,000 and 17,000 deaths in the United
States from IPF per year. Currently, the treatment options are limited
and there is no cure for IPF.

About Brilaroxazine

Brilaroxazine is a new chemical entity (NCE) that acts on serotonin
signaling pathways. Whilst dysfunctional serotonin (5-HT) signaling in
the brain contributes to the pathophysiology of neuropsychiatric and
neurological diseases, in the lung it leads to IPF and pulmonary
arterial hypertension (PAH). Serotonin signaling derived from activated
5-HT_2A/2B/7 receptors in the lung has been reported to
mediate inflammation, fibrosis and proliferation, and pulmonary
hypertension that are hallmarks of IPF and PAH. Brilaroxazine is a
potent inhibitor of the 5-HT_2A/2B/7 receptors and,
consequently, attenuates these functional changes in a series of highly
recognized translational animal models proven to emulate IPF and PAH
conditions in humans.

PAH and neuropsychiatric symptoms are among the major comorbidities in
patients with IPF. Reviva has already successfully completed a
multicenter, multinational phase 2 clinical study for brilaroxazine in
patients with schizophrenia and schizoaffective disorders where it
demonstrated robust efficacy with remission in acute schizophrenia and
promising efficacy for comorbid negative, cognition, depression and mood
symptoms. Moreover, brilaroxazine showed an excellent safety and
tolerability profile compared to the placebo with no weight gain,
metabolic, cardiac or movement side effects, which resulted in good
acceptance and compliance. Data from preclinical and clinical studies
with brilaroxazine are currently available in several published research
articles in peer reviewed journals (http://revivapharma.com/publications/).

About Reviva Pharmaceuticals

Reviva is located in Cupertino, California and is a clinical stage
pharmaceutical company focused on developing a portfolio of internally
discovered next generation therapies that address unmet medical needs in
the therapeutic areas of the central nervous system (CNS), metabolic and
inflammatory diseases. Reviva has a strong patent portfolio and several
products in the pipeline at various stages of development.

Reviva’s leadership team has a proven background and a track record in
successful product development, regulatory approval and
commercialization. For additional information, please visit our website
at www.revivapharma.com.

Forward Looking Statements

This press release contains forward-looking statements made pursuant to
the “safe harbor” provisions of the Private Securities Litigation Reform
Act of 1995. Forward-looking statements reflect management’s current
knowledge, assumptions, judgment and expectations regarding future
performance or events, they give no assurance that such expectations
will prove to be correct. Forward-looking statements are subject to a
number of risks and uncertainties, but not limited to, our liability to
obtain additional capital on acceptable terms, or at all, including
additional capital which will be necessary to complete the clinical
trials, delays caused by institutional review boards or regulatory
agencies, enrollments, shortage of clinical trial supplies, dependence
on clinical trial collaborators, loss of any executive officers or key
personnel or consultants. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the
date on which they are made, and the facts and assumptions underlying
the forward-looking statements may change. Except as required by law,
Reviva disclaims any obligation to update these forward-looking
statements to reflect future information, events or circumstances.

Contacts

Reviva Pharmaceuticals, Inc.
Laxminarayan Bhat, PhD
Founder,
President and CEO
E-mail: [email protected]