Cidara Therapeutics Announces Initiation of Phase 2a Human Viral Challenge Trial to Evaluate CD388 for Universal Prevention of Influenza
Cidara Therapeutics, Inc., a biotechnology company developing long-acting therapeutics designed to help improve the standard of care for patients facing serious diseases, today announced the initiation of its Phase 2a trial to evaluate the pre-exposure prophylactic activity of CD388 against influenza virus.
CD388 is a highly potent, long-acting antiviral designed to deliver universal prevention of seasonal and pandemic influenza. The study is being conducted under an exclusive worldwide license and collaboration agreement with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize Cidara’s Cloudbreak® drug-Fc conjugates (DFCs) for the prevention of seasonal and pandemic influenza.
The Phase 2a trial (NCT05523089), which dosed its first healthy volunteer on September 10th, is a single-center, randomized, double-blind, placebo-controlled, proof-of-concept study to assess the prophylactic antiviral activity, safety, tolerability and pharmacokinetics of CD388 against influenza via a human viral challenge (influenza) model, and to explore the impact of dose levels on efficacy. Multiple dose levels of CD388 will be evaluated in volunteers who will receive a single administration of CD388 or placebo prior to influenza viral challenge. The trial is expected to enroll up to 168 healthy adults.
“The initiation of this Phase 2a trial is an important milestone, as it represents the first study in which CD388’s prophylactic potential against influenza will be examined in humans,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “Because of its mode of action, CD388 has the potential to enable universal influenza coverage against all viral strains for all people, including those with compromised immune systems. We look forward to announcing the findings next year, and continuing our collaboration with Janssen who will be spearheading late-stage development.”
Cidara’s Cloudbreak DFCs, which stably couple highly potent small molecules or peptides to a proprietary composition of a human antibody fragment (Fc), is a fundamentally novel approach to treat and prevent serious viral infections and cancers. For influenza, the long-acting CD388 DFC is designed to directly inhibit viral proliferation by targeting a conserved region on the viral envelope, potentially conferring universal prevention of Types A and B influenza with a single seasonal dose.
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