Positive results from influenza human challenge study conducted by hVIVO
Pneumagen to advance antiviral candidate into further clinical studies
hVIVO plc (AIM & Euronext: HVO), the world leader in testing infectious and respiratory disease products using human challenge clinical trials, notes the announcement by Pneumagen, a clinical-stage biotech company, reporting successful clinical proof of concept for its broad-spectrum antiviral candidate Neumifil, demonstrated from a Phase 2a influenza human challenge study conducted by hVIVO.
The randomised, double-blind, placebo-controlled study enrolled 104 healthy adult volunteers, recruited through the FluCamp platform, and evaluated two dose regimens of Neumifil, administered as an intranasal spray to participants who were subsequently infected with influenza virus.
Based on these positive clinical results, taken together with a pre-clinical data package demonstrating Neumifil’s activity against a broad range of viruses, Pneumagen now plans to advance Neumifil into further clinical studies. This will include the evaluation of Neumifil’s ability to reduce the incidence of viral induced exacerbations in patients with Chronic Obstructive Pulmonary Disease (“COPD”).
Neumifil demonstrated a clinically significant reduction in the incidence of symptomatic influenza infection and in the severity of symptoms, which achieved statistical significance compared to placebo. Neumifil was well tolerated with no new emergent adverse events or safety signals from the study compared to its first in human study.
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “We are delighted to see Pneumagen obtain these results clearly achieving clinical proof of concept for Neumifil, which has supported Pneumogen’s decision to progress the candidate into further clinical studies, including in patients with COPD. This is another example of the value of human challenge trials in delivering clinical efficacy data and de-risking later clinical development.”