Friday, May 27, 2022
Altesa BioSciences, Inc., a clinical-stage biopharmaceutical company developing and commercializing novel antiviral drugs against common respiratory viruses and global viral threats, has U.S. Food & Drug Administration approval to proceed with a clinical study of a promising antiviral treatment, vapendavir. Accordingly, Altesa will initiate this trial and a series of others later this year and early next year, respectively.
Brett P. Giroir, MD, Altesa Chief Executive Officer and former United States Assistant Secretary for Health, announced the news today at the 2022 AdvanSE Life Science Conference in Atlanta.
“The green light from the FDA in response to our investigational new drug application (IND) is a significant step forward as we continue the clinical development of vapendavir, a Phase 2 oral antiviral drug,” Dr. Giroir said. “We believe vapendavir is well poised to mitigate the serious consequences resulting from viral respiratory infections in vulnerable populations. We are committed to evaluating its safety and effectiveness for patients in need.”
The broad spectrum viral capsid inhibitor, vapendavir, is Altesa’s lead clinical stage antiviral drug, which was in-licensed in 2021. Based on prior evaluations in nearly 700 trial participants and patients, vapendavir was well tolerated and showed clear evidence of an antiviral response.
Andrea True Kelly, PhD, Altesa’s Vice President of Clinical Development and Medical Affairs (formerly with Trimeris and Istari), said Altesa will initiate a clinical study this year to evaluate a new formulation of vapendavir. The study will be rapidly followed by Phase 2b clinical trials in 2023 to treat viral infections in vulnerable patients living with chronic obstructive pulmonary disease (COPD).
“Our goal at Altesa is to provide simple, safe, and effective treatments, especially for those at greatest risk from the most common viral respiratory infections,” Dr. Kelly said. “We look forward to finalizing our development partners and initiating trials for this promising therapy in the coming months.”
Over 16 million Americans suffer from COPD, the 4th leading cause of mortality in the U.S., which is anticipated to account for over $800 billion in direct medical expenditures from 2019 through 2038. Rhinoviruses, typically responsible for the common cold, are one of the viruses most commonly associated with serious disease exacerbation in patients suffering from COPD. In healthy individuals, rhinoviruses generally cause self-limiting upper respiratory tract infections, but in people with COPD, infection is readily associated with persistent lung inflammation, airflow obstruction and frequently with secondary bacterial infections, all of which can be life-threatening. By targeting rhinovirus, vapendavir holds great promise to reduce the severity of – or possibly prevent – exacerbations in infected patients with COPD.