Cidara Therapeutics Announces Completion of Enrollment in Phase 3 Restore Trial of Rezafungin in China
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Top-line data expected in Q2 2024
SAN DIEGO, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology developing therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the company, along with Mundipharma, has completed enrollment in the Phase 3 ReSTORE trial in China evaluating the efficacy and safety of rezafungin as a treatment for candidemia and invasive candidiasis.
The portion of the trial conducted in China included 52 patients diagnosed with candidemia and/or invasive candidiasis. ReSTORE (NCT03667690) is a global, randomized, double-blind, controlled Phase 3 pivotal clinical trial evaluating the efficacy and safety of once-weekly intravenous dosing of rezafungin compared to once-daily dosing of caspofungin, the current standard of care, to treat patients with candidemia and/or invasive candidiasis.
“The completion of this trial enrollment marks a significant step in our efforts to bring an important treatment option to patients living with difficult to treat candidemia and invasive candidiasis,” said Taylor Sandison, M.D., MPH, chief medical officer of Cidara. “Rezafungin has demonstrated its benefit for patients in the U.S. and E.U., and now there is the potential to target an even broader global patient population who are suffering and in need of a new treatment option.”
Jeffrey Stein, Ph.D., president and chief executive officer of Cidara stated, “We appreciate the hard work of our investigators involved in this trial, and the patients who have helped us achieve this key milestone. Our team looks forward to the availability of the results of this study in the second quarter of next year and the potential to expand the reach of this treatment for patients. Moreover, the completion of this trial will reduce our cash burn longer-term and makes us eligible to receive additional regulatory and commercial milestone payments.”
Rezafungin received U.S. Food and Drug Administration approval in the U.S. earlier this year, as well as a positive CHMP opinion in October for patients in the European Union. A final decision by the European Medicines Agency (EMA) is expected to be delivered next month. Melinta Therapeutics has the exclusive commercialization rights to REZZAYOTM (rezafungin for injection) in the U.S. and Mundipharma has the commercialization rights to rezafungin in all geographies other than the U.S. and Japan.
About Cidara Therapeutics
Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO™ (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
