Cidara’s Presentations At American Society of Hematology 2016 To Highlight Potential Role Of Novel Antifungal CD101 In Patients With Hematologic Malignancies

SAN DIEGO--(BUSINESS WIRE)--Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that data from preclinical and clinical studies evaluating its novel echinocandin antifungal CD101 will be presented at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in San Diego from December 3-6, 2016. CD101 is Cidara’s lead antifungal drug candidate and the only long-acting antifungal in the echinocandin class.

“Invasive fungal infections remain a significant threat in patients with hematological cancer and in transplant recipients. Although significant progress has been made in diagnostics and the introduction of new agents, significant challenges remain”

“Patients with blood cancers and those undergoing transplantation are at much higher risk for opportunistic fungal infections, often the cause of significant morbidity and mortality,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “We are pleased to be sharing data at this year’s ASH meeting that demonstrate the potential of our novel compound CD101 to treat and prevent deadly fungal infections in blood cancer patients.”

CD101 data accepted for presentation at this year’s ASH Annual Meeting comprise the following:

• Two poster presentations evaluating the efficacy of CD101 for the treatment and prevention of invasive fungal infections due to the pathogens, Candida, Aspergillus and Pneumocystis.
• A poster presentation summarizing results from the successful Phase 1 clinical trial of CD101 IV, demonstrating the safety and pharmacokinetics of single and multiple weekly dosing regimens.

Approximately 97,000 Americans die from hospital-related fungal infections each year and 90 percent of these infections are caused by two common fungi, Candida and Aspergillus. 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. Pneumocystis is another serious fungal infection that commonly afflicts people with weakened immune systems.

“Invasive fungal infections remain a significant threat in patients with hematological cancer and in transplant recipients. Although significant progress has been made in diagnostics and the introduction of new agents, significant challenges remain,” said Dimitrios P. Kontoyiannis, M.D., of The University of Texas MD Anderson Cancer Center. “Current antifungals have several issues with suboptimal pharmacokinetics, frequent drug-to-drug interactions and contraindications with chemotherapy or immunosuppressants, toxicity and suboptimal efficacy, especially as fungal resistance is on the rise. There is an unmet need for new antifungal therapies that are safe and effective with low toxicity.”

Details for the Cidara ASH 2016 presentations are as follows:

Saturday, December 3 – Session 721: Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities - Poster I (5:30 p.m. - 7:30 p.m. PT, Hall GH)

• Pharmacokinetics, Safety, and Target Attainment of Single and Multiple Doses of CD101 IV; T Sandison, et. al. #2197

Sunday, December 4 – Session 721: Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities - Poster II (6:00 p.m. - 8:00 p.m. PT, Hall GH)

• Efficacy of CD101, a Novel Echinocandin, in Mouse Models of Aspergillosis and Azole-Resistant Disseminated Candidiasis; V. Ong, et. al. #3400
• Efficacy of CD101, a Novel Echinocandin, in Prevention of Pneumocystis Pneumonia (PCP): Thwarting the Biphasic Life Cycle of Pneumocystis; M. Cushion, et. al. #3396

Abstracts can be found at www.hematology.org and copies of these poster presentations will also be available on the Cidara website following the meeting: http://www.Cidara.com/

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, CD101, through Phase 2 studies in two indications and developing CD201, its bispecific antimicrobial immunotherapy, for the treatment of multi-drug resistant bacterial infections. CD101 IV has enhanced potency and is the only once-weekly therapy intended for the treatment and prevention of life-threatening invasive fungal infections. CD101 topical is the first and only agent of its class being studied for the treatment and prevention of vulvovaginal candidiasis (VVC), a prevalent mucosal infection. CD201 is the first drug candidate selected from Cidara’s novel Cloudbreak™ platform, the first immunotherapy discovery platform designed specifically to create compounds that 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.

Forward-Looking Statements

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 effectiveness, safety, long-acting nature, anticipated human dosing and other attributes of CD101, and its potential to treat infections, including infections associated with hematologic malignancies and transplantation. 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.