Open Orphan PLC (AIM:ORPH, OTC:OPORF) has highlighted positive results of a human challenge study assessing Enanta Pharmaceuticals (NASDAQ:ENTA)’ respiratory syncytial virus (RSV) antiviral candidate, EDP-938, which is being advanced by Enanta Pharmaceuticals (NASDAQ:ENTA) Inc.
AIM-quoted Open Orphan, which is a contract research organisation (CRO) specialising in the testing of infectious and respiratory disease products, helped facilitate the challenge trial which enrolled 178 healthy adult volunteers in an age range between 18 and 55.
Open Orphan’s subsidiary hVIVO conducted the Phase 2a, double-blind, placebo-controlled trial using its RSV Human Challenge Study Model.
Volunteers received either a dose of EDP-938 or placebo for five days after infection, with different dose levels of EDP-938, and, the study demonstrated that both viral load and clinical symptoms were significantly lower in volunteers that received EDP-938 than those that received placebo.
"We are delighted to see that this important Phase 2a study of EDP-938 has yielded such positive results,” said Cathal Friel, Open Orphan chief executive.
“We are a world leader in testing infectious and respiratory disease products using challenge studies such as this, and RSV is just one portion of our portfolio of challenge models, which also includes influenza, HRV, malaria, asthma, and now SARS-CoV-2.
Friel added: “We look forward to continue offering our world-class services to partners as we look to meet the growing demand from the infectious disease market."
hVIVO chief scientific officer Dr Andrew Catchpole, meanwhile, added: “It's pleasing to see another of our clients getting such positive results from a human challenge study that we conducted, and that the data has been published in The New England Journal of Medicine.
“EDP-938 is a potentially important medicine that could help reduce the global impact of RSV, and I look forward to following Enanta's continued progression of the candidate through further clinical trials."
RSV is a contagious, common respiratory virus that usually causes mild, cold-like symptoms and affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties.