Altesa BioSciences Announces Clearance of Investigational New Drug (IND) Application for Vapendavir

Treat underlying cause of COPD versus maintaining status quo of expensive, chronic therapies 

COLLEGE PARK, Ga., March 19, 2025 /PRNewswire/ -- Altesa BioSciences, Inc., a clinical-stage pharmaceutical company dedicated to developing new treatments for viral infections in vulnerable populations, today announced that the U.S. Food and Drug Administration (FDA) has cleared Altesa's new Investigational New Drug (IND) application for vapendavir for the treatment of rhinovirus infections in people living with COPD. This milestone paves the way for Altesa to initiate clinical trials in the United States for this patient population.

"Viral infections are the primary cause of acute deteriorations in lung function and overall health for those living with COPD. Among viral causes, rhinovirus -- the predominant cause of the common cold -- is the most frequent," said Dr. Brett Giroir, CEO of Altesa BioSciences and former US Assistant Secretary for Health and former Acting FDA Commissioner. "The new IND allows us to advance our studies in COPD, already ongoing in the United Kingdom, into the United States." Altesa already has an open IND for vapendavir to treat rhinovirus infections in people with asthma." 

Vapendavir, taken orally in pill form, is a broad-spectrum antiviral medicine that prevents the virus from entering human cells and reproducing. It exhibits potent activity across 97% of rhinoviruses and other respiratory enteroviruses. Altesa BioSciences holds exclusive global rights to develop, manufacture, and commercialize vapendavir. 

More than 16.4 million Americans, or 6.6% of U.S. adults, suffer with COPD, which is now among the leading causes of death in the US and globally. Those with limited financial resources, especially those in urban and rural areas, are often diagnosed late, which is associated with worse overall outcomes. 

In developing vapendavir, Altesa is applying Dr. Giroir's lessons learned from leading testing and diagnostics for the White House Coronavirus Task Force in 2020. Specifically, he said, "our investments in widely accessible diagnostics now enable treatment of the right patient, at the right time, with the right medicine." It is time to apply these lessons to viral infections that cause suffering in our vulnerable populations every year. 

Vapendavir, Dr. Giroir continued, also holds strong promise to help other patient groups, including those with asthma, other lung diseases, and cancer, and for treating rhinovirus infections in children – a leading cause of pediatric hospitalizations. Altesa's goal is to prevent acute and chronic complications of viral infections in people at risk, and to disrupt the current paradigm of costly, chronic, immune-modifying therapies by instead treating the underlying cause of the acute disease. 

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SOURCE Altesa Biosciences Inc.