SAN DIEGO--(BUSINESS WIRE)--Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that the first trial site has been activated for ReSTORE, a Phase 3 clinical trial evaluating the efficacy and safety of the company’s lead antifungal, rezafungin, to treat candidemia and invasive candidiasis. Rezafungin is a novel echinocandin antifungal being developed as a once-weekly, high-exposure therapy for the treatment and prevention of serious invasive fungal infections.
“Given the compelling data from our Phase 2 program, we are very pleased to initiate our global Phase 3 program of rezafungin,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “Difficult-to-treat, invasive Candida infections are associated with a high mortality and affect the most vulnerable patients. Rezafungin has the potential to be the first new antifungal approved for this indication in over a decade and, given how the drug works, it has the potential to improve outcomes for patients and allow them to leave the hospital earlier, resulting in reduced healthcare costs.”
ReSTORE 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 in patients with candidemia and/or invasive candidiasis. The trial design will be similar to the company’s Phase 2 STRIVE study, which met its primary safety and efficacy objectives. The ReSTORE trial is designed to evaluate one rezafungin dosing regimen of 400 milligrams (mg) for the first week followed by 200 mg of rezafungin once weekly for up to four weeks in total. This treatment arm will be compared to caspofungin in a 1:1 randomization.
The primary efficacy endpoint of ReSTORE, which will be used for a U.S. Food and Drug Administration (FDA) New Drug Application submission, is all-cause mortality at day 30. The primary efficacy endpoint for the European Medicines Agency (EMA) is expected to be global response at day 14.
“I am very enthusiastic about the initiation of this important trial of rezafungin as a once-weekly echinocandin which may offer a new solution for patients and physicians to treat serious invasive Candida infections,” said Cornelius J. Clancy, M.D., Associate Professor of Medicine and Director of the Mycology Research Unit and XDR Pathogen Lab at the University of Pittsburgh. “There is an urgent and growing need for new therapeutic approaches for these infections, which typically afflict highly vulnerable patients, including those who are critically ill and have compromised immune systems. Rezafungin has the potential to overcome the significant limitations associated with current standards of care such as sub-optimal dosing, increasing resistance, drug-drug interactions and toxicities, all of which complicate therapy in patients who are already ill.”
The ReSTORE trial will enroll approximately 184 modified intent-to-treat, or mITT, patients and is expected to generate topline data in 2020. This global trial is anticipated to be conducted at approximately 100 clinical trial centers across the United States, Europe, Asia and Australia.
About Candidemia/Invasive Candidiasis
Over 90 percent of invasive fungal infections begin in the hospital setting. Invasive candidiasis and candidemia comprise the majority of invasive fungal infections in intensive care units, internal medicine and hematology wards within hospitals. Invasive candida infections are considered to be serious and life-threatening and are associated with high rates of morbidity and mortality. According to the Centers for Disease Control and Prevention (CDC) surveillance data, the 30-day all-cause mortality among people with candidemia is approximately 30 percent.
Rezafungin is a novel antifungal echinocandin being developed as a once-weekly, high-exposure therapy for the treatment and prevention of serious invasive fungal infections. Rezafungin has a unique pharmacokinetic profile with a prolonged half-life and front-loaded plasma exposure which, in contrast to all other echinocandins, allows for once-weekly IV therapy. Rezafungin is being studied to address unmet needs in the treatment of candidemia and invasive candidiasis as well as for prophylaxis (prevention) of invasive fungal infections, including Candida, Aspergillus and Pneumocystis in patients undergoing an allogeneic bone marrow transplant. In the recent Phase 2 STRIVE trial, data showed that once-weekly intravenous dosing of rezafungin was generally well tolerated and safe in patients with candidemia and/or invasive candidiasis.
About Cidara Therapeutics
Cidara is a clinical-stage biotechnology company focused on developing new anti-infectives that have the potential to transform the standard of care and save or improve patients’ lives. The company is currently advancing its novel echinocandin antifungal, rezafungin acetate, formerly known as CD101 IV, through clinical trials. Rezafungin has improved pharmacokinetics compared to existing echinocandins and the potential for expanded utility across patient settings. It is the only once-weekly product candidate in development for the treatment and prevention of life-threatening invasive fungal infections. The company’s Phase 2 STRIVE clinical trial of rezafungin met its primary safety and efficacy objectives, and provides support for Cidara to initiate Phase 3 pivotal trials in the treatment of candidemia and invasive candidiasis and the prophylaxis of invasive fungal infections. Cidara is also leveraging its novel Cloudbreak™ platform to develop antibody-drug conjugates for the treatment of serious viral and Gram-negative bacterial infections. Cloudbreak is the first immunotherapy discovery platform designed specifically to create compounds that directly kill pathogens and also direct a patient’s immune cells to attack and eliminate bacterial, fungal or viral pathogens. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, Cidara’s ability to successfully commence and complete Phase 3 clinical trials, the design and timing of those clinical trials, the potential for rezafungin to successfully treat or prevent invasive fungal infections and represent an improvement over current approaches, and Cidara’s ability to successfully complete development of rezafungin and receive regulatory approval for any indication. Risks that contribute to the uncertain nature of the forward-looking statements include: the success and timing of Cidara’s preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; changes in Cidara’s plans to develop and commercialize its product candidates; Cidara’s ability to obtain additional financing; Cidara’s ability to obtain and maintain intellectual property protection for its product candidates; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Cidara’s Form 10-Q most recently filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cidara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.