The Conversation (0)
Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company applying its proprietary Cloudbreak ® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced it presented late-breaking Phase 2b clinical data on its non-vaccine influenza preventative candidate, CD388, during ID Week 2025, taking place October 19-22, 2025, in Atlanta, GA.
"We are pleased to share additional data from our Phase 2b NAVIGATE study at ID Week which further validates CD388 as a potential once per season influenza preventative option," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "These recent safety and efficacy results showcase CD388's potential to offer up to 76.1% prevention efficacy against influenza A and B in healthy, unvaccinated adults. The new virology data presented further reinforces our dose selection for our ongoing Phase 3 ANCHOR study, which aims to evaluate CD388 in individuals with immune compromised conditions, high-risk co-morbidities, or those over the age of 65."
Presentation Title: 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
Presenter: James Alexander MD, MPH, FIDSA
Session: Extra, Extra! New Info on Treating and Preventing RSV and Influenza
Session Location: B401-B402
Session Date and Time: Monday, October 20, 2025, 3:15 PM - 4:30 PM ET
Summary: CD388's safety and prevention efficacy (PE) against influenza A and B in healthy, unvaccinated adults were evaluated in a double-blind, randomized, placebo-controlled, Phase 2b study. Each CD388 dose tested provided significant PE versus placebo: 57.7% (150 mg of CD388), 61.3% (300 mg of CD388), and 76.1% (450 mg of CD388). CD388 was well tolerated with no apparent safety issues. The results suggested that a single dose of CD388 could have the potential to provide season-long prevention of influenza illness in individuals not adequately protected by available influenza vaccines.
About Cidara Therapeutics
Cidara Therapeutics is using its proprietary Cloudbreak ® platform to develop novel DFCs comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment. Cidara's lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 was granted Fast Track Designation by the FDA. Cidara announced positive top-line results from its Phase 2b NAVIGATE trial in June 2025 and initiated its Phase 3 ANCHOR trial in September 2025. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com .
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "anticipates," "expect," "intends," "believes," "may," "plan" or "will". Forward-looking statements in this release include, but are not limited to, statements related to the potential benefits of, and future plans for CD388, and whether it will be approved as a once per season influenza preventative option. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara's clinical trials and other risks related to clinical development, delays in action by regulatory authorities, other obstacles associated with the enrollment of participants or other aspects of CD388 or other DFC development, having to use cash in ways other than as expected and other risks and uncertainties associated with Cidara's business in general. These and other risks are identified under the caption "Risk Factors" in Cidara's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025 and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com
MEDIA CONTACT:
Michael Fitzhugh
LifeSci Communications
(628) 234-3889
mfitzhugh@lifescicomms.com
