Cidara Therapeutics Inc.
09/23/2024 | Press release | Distributed by Public on 09/23/2024 06:11
Material Event Form 8 K
Item 8.01 Other Events.
On September 23, 2024, Cidara Therapeutics, Inc. (the "Company") announced the dosing of the first subject in the Company's Phase 2b NAVIGATE trial to evaluate the efficacy and safety of CD388 for the pre-exposure prophylaxis of influenza during the current flu season.
The Phase 2b clinical trial is expected to be a randomized, double blind, controlled trial targeting 5,000 healthy unvaccinated adult subjects who are not at risk of complications from influenza. Three CD388 dose groups or placebo will be administered to subjects as a single dose at the beginning of the influenza season. Subjects will then be followed for the remainder of the influenza season to monitor for breakthrough cases. Rates of laboratory and clinically-confirmed influenza will be compared between subjects receiving the various single doses of CD388 or placebo. The study is expected to include sites in the United States and United Kingdom.
Forward-Looking Statements
This Current Report on Form 8-K contains "forward-looking statements" which include, but are not limited to, all statements that do not relate solely to historical or current facts, such as statements regarding the Company's expectations, intentions or strategies regarding the study design, timing and locations for the Phase 2b NAVIGATE clinical trial for CD388 and the potential impact and benefits of CD388 on influenza. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. The Company's expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks, and changes in circumstances, including but not limited to risks and uncertainties related to unanticipated delays in or negative results from Cidara's clinical trials and other risks related to clinical development and other risks and uncertainties from time to time described in the Company's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024 filed with Securities and Exchange Commission ("SEC") on August 13, 2024, and in the Company's other filings with the SEC. The Company cautions that the foregoing list of factors is not exclusive and not to place undue reliance upon any forward-looking statements which speak only as of the date made. Except as required by law, the Company does not undertake any obligation to update publicly any forward-looking statements for any reason after the date of this Current Report on Form 8-K to conform these statements to actual results or to changes in its expectations.