SAN DIEGO, Calif.—Cidara Therapeutics, a biotechnology company developing anti-infectives, announced today that the U.S. Food and Drug Administration (FDA) has granted both Qualified Infectious Disease Product (QIDP) and Fast Track designations for the company’s prophylaxis development program for lead antifungal product candidate, rezafungin for injection. The QIDP designation is for the development of rezafungin for the prevention of invasive fungal infections in adults undergoing allogeneic bone marrow transplantation. Cidara had previously announced QIDP designation for rezafungin for the treatment of invasive fungal infections caused by Candida.
“This important FDA designation provides significant support for the development of rezafungin in the hematology setting,” noted Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “We now have the opportunity to expedite the development of rezafungin to address significant unmet needs both in the prevention of invasive fungal infections in immunocompromised patients undergoing bone marrow transplantation, as well as for the treatment of patients with existing severe invasive fungal infections.”
Cidara is developing rezafungin, a novel antifungal echinocandin, as a once weekly high-exposure therapy for the treatment and prevention of serious invasive fungal infections. Rezafungin is being studied to address unmet needs in the treatment of candidemia and invasive candidiasis, as well as for prophylaxis of invasive fungal infections due to common fungal pathogens Candida, Aspergillus and Pneumocystis. No one agent is currently approved to prevent infections caused by these pathogens, and current prophylaxis regimens often require multiple antifungal drugs with safety and tolerability issues. Cidara plans to commence the Phase III ReSPECT prophylaxis clinical trial of rezafungin in patients undergoing allogeneic bone marrow transplantation in the first quarter of 2019.
Approximately 97,000 Americans die from hospital-related invasive fungal infections each year and 90 percent of these infections are caused by two common fungi, Candida and Aspergillus. Pneumocystis Pneumonia is another serious fungal infection that commonly afflicts people with weakened immune systems. Systemic fungal infections typically affect patients whose immune systems have been compromised, such as patients undergoing organ or bone marrow transplantation or chemotherapy, including patients with hematologic malignancies, or patients in intensive care units and those with prolonged hospital stays.
The QIDP designation, provided under the Generating Antibiotic Incentives Now (GAIN) Act, offers certain incentives for the development of new antifungal and antibacterial drugs, including Fast Track, priority review and, if rezafungin is ultimately approved by the FDA, eligibility for an additional five years of marketing exclusivity. Fast Track designation enables more frequent interactions with the FDA review team to expedite drug development. To achieve QIDP designation, a drug candidate must be intended to treat serious or life-threatening infections, particularly those caused by bacteria and fungi that are resistant to treatment, or that treat qualifying resistant pathogens identified by the FDA. These listed qualified pathogens include Candida and Aspergillus species, which have the potential to pose a serious threat to public health.
Cidara is currently advancing rezafungin acetate, formerly known as CD101 IV, through clinical trials. Rezafungin reportedly 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 II STRIVE clinical trial of rezafungin met its primary safety and efficacy objectives, and provides support for Cidara to initiate Phase III pivotal trials in the treatment of candidemia and invasive candidiasis and the prophylaxis of invasive fungal infections.
Cidara also plans to leverage its Cloudbreak platform to develop antibody-drug conjugates for the treatment of serious viral and Gram-negative bacterial infections. The company says that 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.