hVIVO upbeat on positive human challenge trial results with client

Specialist contract research organisation hVIVO announced positive results from a phase 2a human challenge trial (HCT) for Enanta Pharmaceuticals' RSV antiviral candidate, EDP-323, on Monday.

The AIM-traded firm said the trial, which it conducted, tested EDP-323 in 142 healthy adult volunteers, demonstrating the drug's efficacy in treating respiratory syncytial virus (RSV) infections.

EDP-323, a novel oral antiviral that had Fast Track designation from the US Food and Drug Administration (FDA), was tested in three cohorts - a high-dose group, a low-dose group, and a placebo group.

The results showed that EDP-323 was well-tolerated and produced significant reductions in viral load and clinical symptoms.

Specifically, the trial demonstrated an 85% to 87% reduction in viral load area under the curve (AUC) by qRT-PCR and a 97% to 98% reduction in infectious viral load AUC by viral culture compared to placebo.

The total clinical symptoms score also showed a reduction of 66% to 78%, all with a high level of statistical significance.

hVIVO said the findings highlighted the effectiveness of human challenge trials in providing early efficacy data and reducing risks in later-stage clinical development.

“Enanta's trial demonstrates the depth of actionable insights a comprehensive human challenge trial can provide,” said chief scientific officer Dr Andrew Catchpole.

“We congratulate Enanta on these impressive results, which mark a significant step forward in the development of new medicines to treat respiratory infections such as RSV.”

Dr Catchpole said achieving such positive outcomes underscored the potential of the novel RSV treatment to make an impact on patient care.

“We are proud to provide world leading human challenge trials to support the development of exciting drug candidates which hold the potential to have a positive impact on global health.”

At 1009 BST, shares in hVIVO were down 0.81% at 27.52p.

Reporting by Josh White for Sharecast.com.