hVIVO plc (AIM:HVO), a specialist in conducting human challenge trials across multiple infectious and respiratory indications, on Monday reported positive topline results from a Phase 2b field study conducted by Cidara Therapeutics (Nasdaq:CDTX) evaluating CD388, a non-vaccine preventative for seasonal influenza. hVIVO provided participant recruitment and virology and immunology laboratory services.
The randomised, double-blind, placebo-controlled study enrolled 817 healthy participants at hVIVO's Plumbers Row site via its FluCamp volunteer recruitment arm. Participants received a single dose of CD388 or placebo and were monitored off-site for 24 weeks.
hVIVO's hLAB acted as the sole virology laboratory for the global, multi-site trial, covering approximately 5,000 participants across 61 sites. hLAB performed around 60,000 antibody assays and 450 PCR tests, alongside extensive genotypic and phenotypic analyses at its Canary Wharf facility.
The study met its primary endpoint, showing statistically significant prevention efficacy (p
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Formation Bio acquires worldwide rights to FHND5032 from CTFH
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
Almirall receives China approval for Seysara to treat moderate-to-severe acne