LONDON -- VirTus Respiratory Research Ltd, a leading respiratory-focused contract research organisation (CRO), announced that results from their human rhinovirus challenge model in patients with chronic obstructive pulmonary disease (COPD) provided Altesa BioSciences with compelling evidence to advance their lead drug candidate, vapendavir, into large scale, late-stage clinical trials.

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.”