Cidara Therapeutics to Present Late-Breaking Clinical Phase 2 Data on CD388 at ID Week 2025
投稿者AInvest
2025年10月13日 月曜日 午前 8:02 Et1分で読める
CDTX--
CD388, a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose, is a promising candidate in the fight against influenza. The drug is a part of Cidara's proprietary Cloudbreak® platform, which combines targeted small molecules or peptides with a proprietary human antibody fragment. Cidara's lead DFC candidate, CD388, received Fast Track Designation by the FDA in June 2023 and has shown positive top-line results from its Phase 2b NAVIGATE trial [1].
The Breakthrough Therapy designation granted by the FDA to CD388 for preventing influenza A and B in high-risk adults and adolescents underscores its potential as a non-vaccine prophylactic option for those inadequately protected by existing vaccines [2]. This designation facilitates expedited review and support from the FDA as Cidara moves forward with its clinical development.
Cidara has initiated the Phase 3 ANCHOR trial, which will further evaluate the safety and efficacy of CD388, expanding its study population to include generally healthy adults over 65. The company is headquartered in San Diego, California, and can be reached for more information at www.cidara.com [1].
Cidara Therapeutics will present late-breaking Phase 2 clinical data on its antiviral influenza candidate, CD388, at ID Week 2025. The presentation will detail the safety and efficacy of CD388 for preventing illness due to influenza A and B in healthy unvaccinated participants. CD388 is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose. The company's lead DFC candidate has been granted Fast Track Designation by the FDA and is currently in Phase 3 ANCHOR trial.
Cidara Therapeutics, Inc. (Nasdaq: CDTX) will present late-breaking Phase 2 clinical data on its antiviral influenza candidate, CD388, at the ID Week 2025 conference. The presentation, titled "A Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of CD388, a Novel Drug-Fc-Conjugate, for Prevention of Illness due to Influenza A and B in Healthy Unvaccinated Participants," will be given by James Alexander, MD, MPH, FIDSA. The session is scheduled for Monday, October 20, 2025, from 3:15 PM to 4:30 PM ET, in Atlanta, GA [1].CD388, a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose, is a promising candidate in the fight against influenza. The drug is a part of Cidara's proprietary Cloudbreak® platform, which combines targeted small molecules or peptides with a proprietary human antibody fragment. Cidara's lead DFC candidate, CD388, received Fast Track Designation by the FDA in June 2023 and has shown positive top-line results from its Phase 2b NAVIGATE trial [1].
The Breakthrough Therapy designation granted by the FDA to CD388 for preventing influenza A and B in high-risk adults and adolescents underscores its potential as a non-vaccine prophylactic option for those inadequately protected by existing vaccines [2]. This designation facilitates expedited review and support from the FDA as Cidara moves forward with its clinical development.
Cidara has initiated the Phase 3 ANCHOR trial, which will further evaluate the safety and efficacy of CD388, expanding its study population to include generally healthy adults over 65. The company is headquartered in San Diego, California, and can be reached for more information at www.cidara.com [1].

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