SAN DIEGO, Sept. 27, 2021 — Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, today announced that it will present new clinical and non-clinical data in three on-demand poster presentations, including data on rezafungin clinical safety and pharmacokinetics in people with hepatic impairment, at IDWeek taking place virtually from September 29-October 3, 2021.
Rezafungin is a novel once-weekly echinocandin currently being studied in Phase 3 trials for the treatment and prevention of serious fungal infections, including in critically ill patients. Cidara expects to announce top-line data from its Phase 3 ReSTORE trial by the end of 2021 and anticipates filing a New Drug Application (NDA) in the U.S. and similar regulatory filings outside the U.S. in mid-2022.
On-demand poster presentations will be available on September 29. Presentation details are summarized below.
Title: Effect of Hepatic Impairment on the Safety and Pharmacokinetics of Rezafungin
Presenter: Jade Huguet, Pharm.D., Director, Clinical Pharmacology Altasciences
Poster Session: Medical Mycology
Title: Activity of Rezafungin and Comparator Antifungal Agents Tested Against a Worldwide Collection of Contemporaneous Invasive Fungal Isolates (2019-2020)
Presenter: Cecilia G. Carvalhaes, M.D., Ph.D., Associate Director, JMI Laboratories, Inc.
Poster Session: Novel Agents
Title: A Multicenter, Mixed-Method Evaluation of Delayed Hospital Discharge in Patients with Invasive Candidiasis Receiving Echinocandins
Presenter: Jinhee Jo, Pharm.D., University of Houston
Poster Session: Antimicrobial Stewardship: Trends in Antimicrobial Prescribing
To register and view the full schedule, visit IDWeek’s website here. Copies of the presentations will be made available on the Publications section of Cidara’s website.
Rezafungin is a novel once weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis. The structure and properties of rezafungin are specifically designed to improve upon a clinically validated mechanism intended to enhance its efficacy and safety potential for patients. Cidara is currently conducting a Phase 3 clinical trial with rezafungin for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE trial) and a second Phase 3 clinical trial of once-weekly rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial).
About Cidara Therapeutics
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of new approaches aimed at transforming existing treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to drug-Fc conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak® platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
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,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to our plans to receive top-line data for the Phase 3 ReSTORE trial by the end of 2021 and to file an NDA for rezafungin by mid-2022. 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 pre-clinical or clinical trials, impacts of the COVID-19 pandemic or other obstacles to the development of rezafungin. 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 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.