Friday, June 23, 2023
Cidara Therapeutics, Inc. (Nasdaq: CDTX) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CD388, their novel drug-Fc conjugate (DFC) candidate. CD388 is being developed in collaboration with Janssen Pharmaceuticals for the prevention of influenza A and B infection in high-risk adults who are not adequately protected by available vaccines.
Fast Track designation is given to drugs that treat serious conditions with unmet medical needs, aiming to expedite their development and review process. This designation allows for more frequent interactions with the FDA and potential eligibility for Priority Review.
According to Jeffrey Stein, Ph.D., President and CEO of Cidara, the Fast Track designation for CD388 underscores the need for effective prevention options for individuals who are not well protected by existing influenza vaccines. CD388 has shown promising data in terms of safety and efficacy, and it has the potential to provide a safe and effective solution for high-risk patient populations against both seasonal and pandemic strains of influenza A and B.
Cidara has recently shared interim efficacy and safety data from an ongoing Phase 2a study, conducted in collaboration with Janssen Pharmaceuticals, evaluating CD388's pre-exposure prophylactic activity against the H3N2 influenza A virus strain.