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Press Release

Cidara Therapeutics Announces Publication of Results from In Vivo Study Investigating Novel Antifungal CD101 in Intra-Abdominal Candidiasis (IAC)

Cidara Therapeutics,Inc.
Posted on: 01 Aug 17

Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives including anti-infective immunotherapies, today announced publication of data from an in vivo study investigating the deep tissue distribution of CD101, Cidara’s next-generation echinocandin agent, compared to the current first-line treatment, micafungin, in the setting of intra-abdominal candidiasis (IAC), one of the most lethal forms of invasive candidiasis. The data were published online in Antimicrobial Agents and Chemotherapy (AAC), a journal of the American Society of Microbiology.

While the Infectious Diseases Society of America (IDSA) recommends currently marketed echinocandins as first-line therapy for most types of invasive candidiasis, failure rates of approximately 40 percent and increasing drug resistance have raised concerns about insufficient drug penetration during therapy for IAC. Yanan Zhao, et. al. coordinated and conducted the CD101 IAC study with support from the National Institutes of Health (NIH) to help address this significant clinical need.

The study is the first to use MALDI-MS imaging, a powerful tool that enables investigators to acquire molecular information about drug distributions in tissues, as well as drug quantification methods, in a clinically relevant mouse intra-abdominal abscesses model. It compared single-dose treatments of CD101 to multiple-dose treatments of micafungin at doses that approximated human plasma exposures for each drug at their expected or FDA-approved clinical dose. Results show that CD101 had a dose-dependent four-to-six-fold superior penetration into infectious lesions days after the single CD101 dose as compared to daily micafungin. Importantly, CD101 accumulated at levels that would be expected to prevent mutations leading to antifungal resistance.

“The results from this cutting-edge study showcase the potential advantages of CD101 as compared to currently marketed antifungals to effectively treat an infection for which patients and medical professionals desperately need new treatment options,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “The investigators at PHRI, Rutgers University and University of Pittsburgh should be commended for advancing antifungal drug research with a highly novel and clinically relevant approach in this study. These findings are especially timely given the current outbreak of drug-resistant Candida auris, which has a reported mortality rate as high as 60 percent.”

“The approximately 40 percent failure rate experienced by patients with invasive candidiasis may be related to findings that current echinocandin therapies cannot deliver sufficient concentrations to infection sites,” said David Perlin, Ph.D., executive director and professor, Public Health Research Institute (PHRI), New Jersey Medical School, Rutgers Biomedical and Health Sciences, and senior author of the AAC paper. “The in vivo data published in AAC confirm the potential of CD101 as a future treatment option for patients with IAC because of the extraordinary tissue penetration at the site of infection.”

About Fungal Infections

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. The emergence of a new and virulent fungal infection called Candida auris (C. auris) is also a growing public health concern due its resistance to existing antifungal agents. As of July 2017, the Centers for Disease Control and Prevention (CDC) reports that C. auris has been identified in more than 200 patients in the United States.Cidara is currently evaluating CD101 in C. auris, in addition tomultiple, other invasive fungal infections.

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 IV, through Phase 2 and developing CD201, its bispecific antibiotic immunotherapy, for the treatment of multi-drug resistant Gram-negative bacterial infections. CD101 IV has improved pharmacokinetics compared to existing echinocandins and has the potential for expanded utility across patient settings. CD101 IV is the only once-weekly product candidate in development for the treatment and prevention of life-threatening invasive fungal infections. 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 recently received a grant for up to $6.9 million from CARB-X (Combating Antibiotic Resistant Bacteria Accelerator) to advance the development of CD201. 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, and other attributes of CD101, including the potential for this compound to successfully treat and prevent fungal infections compared to current antifungal agents. 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-K 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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170801005618/en/

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Last updated on: 01/08/2017

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