Cidara Therapeutics Inc (NASDAQ: CDTX) announced 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 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.
A single dose of CD388 decreased influenza viral replication in the upper respiratory tract and lowered influenza incidence rate in a human challenge model compared to a placebo.
The study is being conducted under an exclusive worldwide license and collaboration agreement with Janssen Pharmaceuticals Inc, a unit of Johnson & Johnson (NYSE: 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 (150 mg) and 28 receiving a placebo.
Treatment with CD388 was generally well-tolerated, with no treatment-emergent adverse events leading to study discontinuation or serious adverse events reported in the interim analysis.
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