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LONDON - Contract research organization hVIVO PLC (AIM:HVO) announced Monday that its client Cidara Therapeutics (NASDAQ:CDTX) has achieved positive topline results in a Phase 2b field study for CD388, a drug designed to prevent seasonal influenza.
The randomized, double-blind, placebo-controlled multicenter study met its primary endpoint with statistically significant prevention efficacy across all dose groups, according to a company press release.
hVIVO recruited 817 healthy participants through its FluCamp volunteer arm and performed comprehensive virology and immunology laboratory services for the trial. The company served as the sole virology laboratory for the international study, which included 61 sites and approximately 5,000 participants worldwide.
Results showed that only 0.7% of subjects who received a single 450 mg dose of CD388 developed influenza-like illness over the 24-week study period, compared to 2.8% in the placebo group. The drug also demonstrated efficacy in participants with temperatures of 37.8 and 37.2 degrees Celsius, and maintained effectiveness for an additional month after the trial concluded.
hVIVO’s laboratory conducted approximately 60,000 antibody assays on serum samples and 450 PCR assays on respiratory swabs to detect and quantify influenza virus levels in participant samples.
Following these results, Cidara has submitted an end of Phase 2 meeting request to the FDA to discuss Phase 3 trial design and timing.
Yamin Khan, Chief Executive Officer of hVIVO, described it as the company’s "largest field study clinical conduct and hLAB laboratory support contract to date," highlighting hVIVO’s capability to conduct sizeable field trials beyond its facilities in Canary Wharf and Germany.
CD388 is designed as a non-vaccine preventative for seasonal influenza and had previously demonstrated efficacy in a challenge study conducted by hVIVO.
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