hVIVO plc (LON:HVO), a fast-growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, has noted the announcement by Enanta Pharmaceuticals, reporting positive topline results from a Phase 2a Respiratory Syncytial Virus (RSV) human challenge trial in healthy adults conducted by hVIVO for EDP-323, its second RSV antiviral candidate.
EDP-323, a novel, oral, direct-acting antiviral in development for RSV infection, has made impressive strides, achieving U.S. Food and Drug Administration (FDA) Fast Track designation. The topline results from the HCT involving 142 healthy adult volunteers demonstrate the effectiveness of EDP-323. With participants split into three cohorts (47 receiving a high dose, 47 receiving a low dose and 47 receiving a placebo), the study showed that EDP-323 was generally safe, well-tolerated, and demonstrated a rapid and sustained antiviral effect. The results show an 85-87% reduction in viral load area under the curve (AUC) by qRT-PCR (p<0.0001), a 97-98% reduction in infectious viral load AUC by viral culture (p<0.0001), and a 66-78% reduction of total clinical symptoms score AUC (p<0.0001) compared to placebo.
