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

Rhinovirus infection is the cause of at least half of the acute respiratory deteriorations experienced by the millions of patients with chronic obstructive lung disease. “Before advancing vapendavir into clinical trials testing vapendavir on thousands of patients costing tens of millions of dollars, it was critical to demonstrate beneficial effects of the drug in a proof-of-concept study," said Dr. Brett Giroir, CEO of Altesa and former US Assistant Secretary for Health and Acting FDA Commissioner. “After literally searching the globe, we determined that VirTus was the only place that could safely, effectively, and reliably conduct this study on actual volunteers with COPD.”

The randomised, placebo-controlled study enrolled and evaluated 40 volunteers with COPD, the 3rd leading cause of death worldwide. Pre-screened COPD patients were challenged with a known-to-be safe strain of rhinovirus and randomized after onset of symptoms. Recruitment involved contacting over 10,000 potential volunteers primarily through targeted social media campaigns, highlighting the innovative approach VirTus employs to ensure efficient and successful participant engagement.

"These positive results underline the effectiveness of our human virus challenge model to rapidly assess clinical efficacy of novel medicines early in their clinical development pathway," said Professor Sebastian Johnston, Co-founder and Chief Medical Officer (CMO) at VirTus. "This approach allows our biotech and pharmaceutical industry partners to gain early, meaningful clinical data, helping them to make confident go/no-go decisions in their drug development pipeline."

VirTus' human virus challenge model offers sponsors the opportunity to evaluate treatments in a controlled environment, significantly reducing uncertainty, time and cost associated with much larger, traditional early clinical development studies.

“By leveraging the wealth of experience of Professor Johnston and the VirTus team, we have learned how to best deploy vapendavir so that is has the best chance of improving the lives of people with COPD – which is our ultimate goal and one that I have dedicated my career to achieving,” said Dr. Kate Knobil, CMO at Altesa and former CMO of GSK.

Dr Michael Edwards, Co-founder and Managing Director at VirTus, added, "We're delighted to support Altesa BioSciences in achieving these encouraging results with vapendavir. This successful collaboration showcases the strength and reliability of our human challenge studies, reinforcing our mission to accelerate innovative treatments for respiratory illnesses worldwide."

About VirTus Respiratory Research Ltd

VirTus Respiratory Research Ltd is a CRO co-led by Professor Sebastian Johnston and Dr. Michael Edwards, both of Imperial College London, United Kingdom. VirTus is dedicated to accelerating the development of novel therapies for the treatment and prevention of respiratory virus infections, which are the leading cause of acute attacks (exacerbations) in chronic respiratory diseases such as asthma, COPD and bronchiectasis. VirTus conducts both pre-clinical and early-phase clinical studies, specialising in human virus challenge models to generate high-quality data that supports the advancement of new therapeutics into later-stage development.

The rhinovirus challenge model

At VirTus Respiratory Research Ltd, the rhinovirus challenge model is used to generate early signals of clinical efficacy in a tightly controlled, reproducible setting. By exposing volunteers to rhinovirus infection under monitored conditions, the model provides detailed assessment of how a treatment impacts symptoms, virus load and immune/inflammatory responses. For our partners, this model acts as a critical go/no-go decision maker ahead of much larger, costlier Phase 2b/3 trials. It helps answer key questions early, including clinical efficacy, dose selection and endpoint optimisation. Sponsors benefit from accelerated timelines, early go/no-go insights, de-risking development programs by identifying promising candidates, or ruling out ineffective ones, at an earlier stage, ultimately optimising resource allocation and increasing the likelihood of downstream success.

About Vapendavir

Vapendavir, taken orally in pill form, is a clinical-stage antiviral medicine with potent activity against 97% of rhinoviruses tested and other respiratory enteroviruses. It prevents the virus from entering human cells as well as preventing it from reproducing. Vapendavir is currently in advanced clinical trials for the treatment of rhinovirus infections in people living with COPD. Vapendavir has a similar mechanism of action to the FDA approved HIV capsid inhibitor, lenacapavir marketed by Gilead Sciences.

About COPD

COPD is a life-limiting chronic lung condition that affects hundreds of millions of people worldwide. COPD is now the third leading cause of death globally, with prevalence continuing to rise due to aging populations and ongoing exposure to risk factors such as smoking and air pollution. COPD imposes a huge burden on individuals and healthcare systems alike, with high morbidity due to progressive lung function decline and frequent exacerbations, alongside enormous ($49 billion in the US) healthcare costs associated with long-term treatment and prolonged and frequent hospital admissions.

About Altesa

Altesa BioSciences is a clinical-stage pharmaceutical company dedicated to developing new treatments for age-old threats to human health: high-consequence viral infections. These infections are particularly severe in vulnerable people, including those with chronic health conditions, like lung diseases, as well as the elderly and many people in underserved communities.