Altesa BioSciences announced positive topline results from its Phase 2 placebo-controlled study evaluating vapendavir in COPD patients challenged with rhinovirus. The oral antiviral improved patient-reported measures of both upper and lower respiratory symptoms while shortening the overall course of illness, potentially offering a new approach to managing COPD exacerbations.
The study, conducted by VirTus Respiratory Research Ltd. in London, showed that vapendavir treatment led to reduced viral loads and faster viral clearance in the respiratory system of participants. This milestone follows the recent FDA clearance of Altesa's Investigational New Drug (IND) application for vapendavir, allowing the company to initiate clinical trials in the United States.
"This is the first study that has shown that an antiviral for rhinovirus infection, the most common cause of COPD exacerbations, can have a positive impact on upper and lower respiratory symptoms," said Kate Knobil, MD, chief medical officer of Altesa and former chief medical officer of GSK. "This effect has the potential to reduce the severity of exacerbations or even prevent exacerbations of their disease, which can be devastating for these patients."
The Clinical Challenge of Rhinovirus in COPD
Rhinovirus, the predominant cause of the common cold, is responsible for more than 45% of COPD exacerbations. These acute deteriorations in lung function significantly impact patient quality of life and contribute to disease progression. Currently, treatment options primarily focus on managing symptoms rather than addressing the underlying viral cause.
More than 16.4 million Americans (6.6% of U.S. adults) suffer from COPD, which ranks among the leading causes of death both nationally and globally. Patients with limited financial resources, particularly those in urban and rural areas, often receive delayed diagnoses, resulting in poorer outcomes.
Vapendavir's Mechanism and Potential
Vapendavir is a broad-spectrum antiviral medicine administered orally in pill form. It works by preventing rhinoviruses and related viruses from entering human cells and reproducing. The drug has demonstrated potent activity against 97% of tested rhinoviruses and other respiratory enteroviruses.
"Rhinovirus infection is the most commonly identified cause of exacerbations among COPD patients," explained Dr. Brett Giroir, CEO of Altesa BioSciences and former US Assistant Secretary for Health. "Our vision is to treat these viral infections with a safe and effective oral pill, which will stop the virus in its tracks before it can cause devastating consequences for patients. If we are successful, not only will we save lives and improve the quality of life for patients, but also potentially save billions of dollars in health care expenditures each year."
Altesa BioSciences holds exclusive global rights to develop, manufacture, and commercialize vapendavir, which is currently the only direct-acting antiviral medicine targeting rhinovirus in human clinical trials.
Study Design and Results
The Phase 2 rhinovirus challenge study was designed to closely mimic real-world conditions. Participants, who had Stage 2 COPD, were not isolated during the study but returned to their normal environments after clinical visits. Treatment with vapendavir or placebo began only after participants self-reported symptom onset and continued for seven days.
Participants typically developed upper respiratory symptoms on the second day after viral challenge, followed by worsening lower respiratory symptoms. The study found that vapendavir was well-tolerated with a favorable safety profile—notably, there were more adverse events and more severe adverse events in the placebo group compared to the vapendavir treatment group.
Dr. Giroir noted that the company is applying lessons learned from his experience leading testing and diagnostics for the White House Coronavirus Task Force in 2020: "Our investments in widely accessible diagnostics now enable treatment of the right patient, at the right time, with the right medicine."
Future Directions
Beyond COPD, vapendavir shows promise for treating rhinovirus infections in other vulnerable populations, including those with asthma, other lung diseases, cancer patients, and children—for whom rhinovirus is a leading cause of hospitalization.
The FDA's clearance of the IND application allows Altesa to advance studies already ongoing in the United Kingdom into the United States. The company also has an open IND for vapendavir to treat rhinovirus infections in people with asthma.
Altesa plans to submit more detailed results from the challenge study for presentation at future medical conferences. The company's goal is to shift the treatment paradigm from costly, chronic, immune-modifying therapies to addressing the underlying viral causes of acute exacerbations in vulnerable populations.
