Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that three rezafungin abstracts have been accepted for presentation at the 45th Annual European Society for Blood and Marrow Transplantation (EBMT) Meeting to be held in Frankfurt, Germany from March 24-27, 2019. Rezafungin is a novel echinocandin antifungal and is the only once-weekly product candidate in development for the treatment and prevention of life-threatening invasive fungal infections.
Patients undergoing blood and marrow transplantation are at increased risk of acquiring deadly invasive fungal infections and current prevention strategies require multiple antifungals that are associated with known drug-drug interactions as well as safety and tolerability issues, said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. We believe rezafungin has the potential to transform the fungal prevention paradigm in vulnerable transplant patients by providing a simple one-drug regimen with a potentially superior safety profile.
The EBMT annual meeting is the Societys flagship scientific forum that convenes scientists, healthcare professionals, and patients from Europe and throughout the world to discuss key issues and developments relating to stem cell transplantation and cellular therapy research.
Rezafungin data will be featured in three poster presentations during the Infectious Complications Poster Session, taking place on Tuesday, March 26 from 17:30-19:00 (Central European Time) in the Forum Building, Level 0. Presentation details are as follows:
Title: Drug-Drug Interaction (DDI) Study Between Rezafungin and Nine Probe Drugs Show No Relevant Pharmacokinetic Change Abstract number: B196 Presenter: V. Ong
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Title: Pharmacokinetic-Pharmacodynamic Analyses of Dose Selection for Rezafungin Prophylaxis Against Invasive Fungal Infections in Blood and Marrow Transplantation Abstract number: B214 Presenter: V. Ong
Title: Rezafungin Prophylactic Efficacy in a Mouse Model of Pneumocystis Pneumonia Abstract number: B189 Presenter: T. Sandison
Full abstracts for these studies will be available online approximately two weeks before the meeting on the EBMT website: www.ebmt.org. In addition, copies of the posters will be available on the Cidara website following the meeting: www.cidara.com.
Rezafungin is a novel echinocandin antifungal being developed as a once-weekly therapy to address significant unmet needs in the treatment of candidemia and invasive candidiasis as well as for prophylaxis of invasive fungal infections due to the common fungal pathogens Candida, Aspergillus and Pneumocystis. Cidaras Phase 3 ReSTORE clinical trial for treatment of candidemia and invasive candidiasis is underway. Cidara anticipates commencing the Phase 3 ReSPECT prophylaxis clinical trial of rezafungin in patients undergoing allogeneic blood and marrow transplantation in the first half of 2019, assuming the successful outcome of ongoing discussions with regulatory authorities.
About Invasive Fungal Infections
Invasive fungal infections (IFIs) represent a serious global health threat, resulting in more than 1.5 million deaths annually and mortality rates ranging from 15 to 65 percent. These infections are especially relevant for patients whose immune systems have been compromised, such as patients undergoing organ or blood and marrow transplantation or chemotherapy, including patients with hematologic malignancies. Of the most significant IFIs, approximately 90 percent of related deaths are primarily caused by Candida, Aspergillus, and Pneumocystis. Candida species are most common in hospital-acquired infections, while Aspergillus species are predominant in patients with weakened immune systems or lung diseases. Pneumocystis infections also commonly afflict immunocompromised patients.
About Cidara Therapeutics
Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives that have the potential to transform the standard of care and save or improve patients lives. Cidara is currently advancing its novel echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial, for the treatment of candidemia and invasive candidiasis and continues to discuss with regulatory authorities its plans for the design and the initiation of a second Phase 3 trial in the prophylaxis of invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation. Rezafungin is the only once-weekly product candidate in development for the treatment and prevention of life-threatening invasive fungal infections. Cidara also is leveraging its proprietary Cloudbreak platform to develop antibody-drug conjugates (ADCs) for serious viral and bacterial infections, including further investigation of the high potency and long half-life observed in its antiviral ADCs for influenza. The Cloudbreak platform is designed to discover compounds that both directly kill pathogens and direct a patients immune system to attack and eliminate 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, statements regarding the initiation of rezafungin Phase 3 pivotal trials, the potential for rezafungin to be a novel treatment and prophylactic agent against deadly invasive fungal infections, the potential for rezafungin to provide a simpler dosing regimen and a potentially superior safety profile compared to current therapies, and rezafungins potential for expanded utility across patient settings. Risks that contribute to the uncertain nature of the forward-looking statements include: the success and timing of Cidaras preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; changes in Cidaras plans to develop and commercialize its product candidates; Cidaras ability to obtain additional financing; Cidaras 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 Cidaras 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.
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