Vapendavir Improved Rhinovirus Clinical Course in Patients With COPD

Vapendavir improved overall patient-reported measures of both upper and lower respiratory symptoms and led to a shortened overall course of illness in patients with chronic obstructive pulmonary disease (COPD) challenged with rhinovirus.1

"Rhinovirus infection is the most commonly identified cause of exacerbations among COPD patients – accounting for more than 45% of these flare-ups2," Brett Giroir, MD, CEO of Altesa BioSciences and former US Assistant Secretary for Health and former Acting FDA Commissioner, said in a statement.1 "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," he continued. "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."

Vapendavir is a broad-spectrum antiviral pill taken orally that prevents viral entry into human cells and reproduction for 97% of rhinoviruses tested and other respiratory enteroviruses. It is the only direct-acting antiviral medicine targeting rhinovirus now in human clinical trials; it is currently being assessed for treating rhinovirus infections in people living with COPD. Altesa noted that vapendavir has a similar mechanism of action to Gilead’s FDA-approved HIV capsid inhibitor, lenacapavir.

The challenge study was conducted by VirTus Respiratory Research Ltd. in London, United Kingdom, and co-led by Professor Sebastian Johnston, Professor of Respiratory Medicine & Allergy at the National Heart and Lung Institute, in Imperial College London, and Michael Edwards, PhD, Managing & Scientific Director at VirTus, with collaborators at St. Mary's Hospital.

The challenged study was designed to mimic real-world experience of patients with COPD and started treatment only when their symptoms began to worsen. Participants only received vapendavir or placebo when they self-reported the onset of symptoms. During the study, participants also went home after visits to live in their normal environment.

Participants had Stage 2 COPD and met specific inclusion criteria designed to ensure that the rhinovirus infection would only result in a temporary worsening of their illness. The investigators observed that generally, participants developed an upper respiratory illness on the second day after challenge, followed by worsening of lower respiratory symptoms. After the onset of symptoms, participants received vapendavir for 7 days or placebo. Notably, the investigators found that vapendavir was well tolerated and had a significantly favorable safety profile compared to placebo in terms of both incidence and severity of adverse events. Altesa will present more detailed results at a future medical meeting.

"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. 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," Kate Knobil, MD, chief medical officer of Altesa, added.1 "Vapendavir demonstrated a consistent beneficial effect across numerous important parameters – suggesting this medicine could become a transformative new therapy for the more than sixteen million Americans and hundreds of millions around the world who daily suffer with COPD."

REFERENCES

1. Altesa BioSciences Details Positive Topline Vapendavir Results from Phase 2 Placebo-Controlled Rhinovirus Challenge Study in COPD Patients. News release. Altesa BioSciences. May 7, 2025. https://www.prnewswire.com/news-releases/altesa-biosciences-details-positive-topline-vapendavir-results-from-phase-2-placebo-controlled-rhinovirus-challenge-study-in-copd-patients-302448650.html

2. Wedzicha JA, Role of Viruses in Exacerbations of Chronic Obstructive Pulmonary Disease. Am. Thorac. Soc. 2003; 1(2).