hVIVO plc (Euronext & LON:HVO), (formerly Open Orphan plc) a rapidly 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 Cidara Therapeutics, Inc., reporting positive interim results from an ongoing human challenge study testing CD388. hVIVO is conducting the Phase 2a single-center, randomised, double-blinded, placebo-controlled trial using its H3N2 Influenza Human Challenge Study Model.
CD388 is Cidara’s long-acting drug-Fc conjugate antiviral for the treatment of seasonal influenza. The interim analysis is based on 56 healthy volunteers, with 28 receiving a single dose of CD388 (150 mg) and 28 receiving a placebo. All subjects were then challenged with a H3N2 influenza A challenge agent. Interim results showed a decrease in viral replication in the upper respiratory tract and influenza infection in participants receiving a single dose of CD388 when compared to placebo. CD388 was well-tolerated with no drug -related adverse events observed. The data has established preliminary clinical proof of concept for CD388’s ongoing development programme.
hVIVO has three decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including various strains of influenza, respiratory syncytial virus (RSV), human rhinovirus (HRV – common cold virus), COVID-19, asthma, as well as malaria.
Cidara’s announcement is available at https://www.cidara.com/news/cidara-therapeutics-announces-promising-interim-phase-2a-data-assessing-the-safety-and-efficacy-of-a-single-dose-of-cd388-in-an-influenza-challenge-model/
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “hVIVO boasts a world-leading portfolio of human challenge models, and we are delighted to see the positive interim results outlining CD388’s efficacy against H3N2 influenza, one of the two subtypes responsible for the annual influenza epidemics. The results are another clear demonstration of the value of human challenge trials in delivering quick efficacy data, de-risking entry into later stage clinical development. Importantly, the data underlined the potential of Cidara’s Cloudbreak drug-Fc conjugates, of which CD388 is one example, to be efficacious long-acting therapeutics with universal protection of seasonal and pandemic influenza.”
