Vapendavir, a potential novel treatment for COPD patients with rhinovirus, continues to move forward in clinical development. Altesa BioSciences, manufacturer of the drug, announced that enrollment is underway in the phase 2b CARDINAL multinational trial.
This news comes after the company announced positive results in an earlier trial in 2025. The upcoming CARDINAL trial, which will build on that previous study, is a randomized, placebo-controlled study of 900 COPD patients with rhinovirus infections in the United States and the United Kingdom.
“CARDINAL is designed to answer a fundamental question in COPD care: Can directly targeting rhinovirus change the trajectory of the disease, including exacerbations? Enrolling our first patient brings us meaningfully closer to that answer — and to a potential new option for patients who urgently need one,” said Katherine Knobil, MD, in a press release. Dr. Knobil is chief medical officer of Altesa BioSciences and leader of the study.
The company said the CARDINAL trial is specifically designed to reflect real-world care models, proactively identifying and supporting those at greatest risk. Participants will be closely monitored over time and, upon development of a rhinovirus infection, will be randomized to receive one of two doses of vapendavir or placebo.
The trial’s primary objective is to assess improvement in respiratory symptoms using established patient-reported outcomes. Additional endpoints will evaluate time to symptom resolution, quality of life, healthcare resource utilization and lung function as well as identifying a dose for a future phase 3 study.
“Rhinovirus is responsible for roughly half of all acute COPD exacerbations, yet today, the ability to target this underlying cause falls short,” said Dr. Knobil. “Care has largely focused on managing symptoms after the inflammatory cascade has already begun. Vapendavir was developed to directly target rhinovirus to interrupt this cycle earlier. This transformational, disruptive approach to the treatment status quo represents an opportunity to provide a better approach for respiratory infections in vulnerable patients who want and need better options.”
