Cidara Therapeutics announces interim Phase 2a data of CD388

Cidara Therapeutics (CDTX) announced promising efficacy and safety data from a planned interim analysis of the ongoing Phase 2a trial evaluating the pre-exposure prophylactic activity of CD388 against the H3N2 influenza A virus strain, as of a February 13, 2023 data cut-off. As evidenced by animal efficacy studies, CD388 has the potential to be a long-acting antiviral drug designed to deliver universal prevention of seasonal and pandemic influenza A and B strains. The study is being conducted under an exclusive worldwide license and collaboration agreement with Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), to develop and commercialize Cidara’s Cloudbreak drug-Fc conjugates, DFCs, for the prevention of seasonal and pandemic influenza. The interim analysis is based on 56 subjects, with 28 receiving a single dose of CD388 and 28 receiving a placebo. Despite the small sample size in this planned interim analysis, a decrease in viral replication in the upper respiratory tract and influenza infection was observed in participants receiving a single dose of CD388 when compared to placebo. Treatment with CD388 was generally well-tolerated as of the February 13, 2023 data cut-off, with no treatment emergent adverse events leading to study discontinuation or serious adverse events reported in the interim analysis.