Cidara Therapeutics Completes Enrollment of Phase 2b NAVIGATE Trial Evaluating CD388 for Prevention of Seasonal Influenza

Globe Newswire 4-Dec-2024 8:00 AM

SAN DIEGO, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company using its proprietary Cloudbreak^® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced it has reached full planned enrollment of 5,000 subjects in the Phase 2b NAVIGATE trial across clinical sites in the US and UK. The trial is designed to evaluate the efficacy and safety of CD388, the company's DFC for the pre-exposure prophylaxis of seasonal influenza.

"Completing the NAVIGATE study at the beginning of the northern hemisphere flu season was a critical milestone to evaluate the efficacy and safety of CD388 as a potential long-acting, universal influenza preventative," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Thanks to the efforts of our investigators and clinical teams, we are now well-positioned to advance the study as this year's flu season unfolds."

The Phase 2b NAVIGATE clinical trial is a randomized, double-blind, controlled trial in healthy, unvaccinated adult subjects who are not at risk of complications from influenza. The objective of the study is to evaluate safety, pharmacokinetics and the rates of laboratory and clinically confirmed influenza in subjects receiving the single doses of CD388 (150mg, 300mg, 450mg) or placebo administered once at the beginning of the flu season. Subjects are then followed for the remainder of the influenza season to monitor for breakthrough cases.

About CD388
CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors. CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status. More information can be found at: https://www.cidara.com/cloudbreak/influenza/.

About Cidara Therapeutics
Cidara Therapeutics is using its proprietary Cloudbreak^® platform to develop novel drug-Fc conjugates (DFCs) comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment (Fc). 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 U.S. Food and Drug Administration (FDA), and the Company announced initiation of a Phase 2b trial in September 2024. Additional DFCs have been developed for oncology and in July 2024 Cidara received IND clearance for CBO421 which is intended to target CD73 in solid tumors. 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 of and future plans for CD388, our Phase 2b NAVIGATE trial study design and locations for sites and the impact of new SAB members. 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 on the enrollment of patients or other aspects of CD388 or other DFC development, the impacts of the realignment and restructuring being different than 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 most recent Quarterly Report on Form 10-Q and other filings subsequently made with the SEC. 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.

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