– New Data Support CD101’s Potential as a Potent Treatment for Serious Fungal Infections and Highlight Progress in Company’s Robust Antifungal Drug-Development Program –
Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today announced the presentation of preclinical data from studies demonstrating the unique attributes of Cidara’s lead antifungal drug candidate, CD101, supporting its potential use for treating serious fungal infections. The results are being presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the International Congress of Chemotherapy (ICC) joint meeting in San Diego, September 17-21, 2015.
A total of three oral presentations and 14 posters presented at ICAAC/ICC 2015 highlight results from a broad range of preclinical studies evaluating Cidara’s investigational programs for CD101 IV, CD101 Topical and the Cloudbreak™ targeted immunotherapy platform. The majority of these presentations focus on CD101 IV, providing a description of the compound’s novel design and resulting benefits that differentiate it from first-generation echinocandins. The preclinical studies demonstrate that CD101 is associated with high stability and solubility, potent antifungal activity with high efficacy in animal models, and no toxicity signals.
“Data presented at this year’s ICAAC/ICC meeting establish the breadth, depth and promise of our antifungal drug development program,” said Jeff Stein, Ph.D., president and CEO of Cidara. “We anticipate that the unique attributes of CD101 will translate into a safe, effective and long-acting echinocandin that could benefit patients in fighting both systemic and local fungal infections. We are extremely pleased that data presented this week support this expectation.”
There is a significant unmet need for novel drugs to treat fungal infections associated with high mortality rates and rising drug resistance, typically affecting patients whose immune systems have been compromised. In the United States alone there are an estimated 97,000 deaths per year among patients with hospital-related fungal infections, and nearly 90 percent of these infections are caused by two fungi, Candida and Aspergillus. CD101 IV is currently in Phase 1 clinical development and was recently designated a Qualified Infectious Disease Product (QIDP) with Fast Track status from the U.S. Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis.
“Current antifungal standards of care, including first-generation echinocandins, have multiple limitations, including inconvenient daily IV dosing and dose-limiting toxicities,” said Dirk Thye, M.D., chief medical officer of Cidara. “We are committed to developing a compound that allows for safe and higher dosing on a more convenient schedule to help physicians more effectively treat their patients.”
Highlights of Key CD101 Presentations
Title: Structure-activity Relationship of a Series of Echinocandins and the Discovery of CD101, a Highly Stable and Soluble, Once-weekly Novel Echinocandin; K. James, C. Laudeman, N. Malkar, R. Krishnan, K. Polowy (Abstract F-750)
- This study describes the research path to discover a novel echinocandin with unique properties that would enable alternate routes of administration and a flexible dosing schedule.
- Researchers structurally modified multiple echinocandin platforms through design and synthesis.
- Data from this study show that the most effective compounds exhibited half-lives four-fold (12 to 53 hours) higher than other echinocandins in animal models. Ultimately, researchers selected for nonclinical development the compound with the most desirable combination of efficacy and pharmacokinetic properties – this was CD101.
- The study concluded that CD101 is a novel echinocandin with a unique modification that results in high physical and chemical stability, solubility, and potent, efficacious antifungal activity, as well as a very long plasma half-life compared to structurally similar compounds.
- CD101’s unique properties, including its long half-life, may allow for less frequent IV administration as well as intramuscular, subcutaneous, and topical applications.
Title: Preclinical Evaluation Shows CD101, a Novel Echinocandin, is Highly Stable with No Hepatotoxicity in Rats; V. Ong, G. Hough, M. Schlosser, K. Bartizal, J. Balkovec, K. James, R. Krishnan (Abstract A015)
- This study compared the toxicity of CD101 to a first-generation echinocandin with a focus on assessing chemical-driven liver damage, the known dose-limiting toxicity of echinocandins in animal-safety studies.
- Using an animal-safety model, CD101 was administered by IV infusion in doses comparable to its estimated human plasma exposures. Clinical signs, chemistries, hematology, and liver histopathology were studied.
- CD101 proved to be metabolically stable and did not exhibit chemical-driven liver damage when given at doses up to 20 mg/kg for two weeks.
- Researchers concluded that the stability of CD101 prevents it from breaking down into toxic reactive metabolites, demonstrating potential safety in this animal model. Given that CD101 demonstrated no toxicity, high stability, and longer half-life with lower clearance compared to other echinocandins, it may allow for higher exposures of the drug as a potential approach to prevent and combat drug resistance.
Title: Efficacy of CD101 to Treat Echinocandin-resistant Candida albicans in a Murine Model of Invasive Candidiasis; Y. Zhao, I. Kolesnikova, E. Dolgov, D. Perlin (Abstract F-748)
- This study evaluated the in vivo efficacy of CD101 in treating echinocandin-resistant strains of Candida albicans in an animal efficacy model.
- In this study, animals were administered CD101 or micafungin at doses that are equivalent to the anticipated human drug exposures after a single IV dose at three hours post-inoculation.
- Results show that CD101 was highly effective in treating both echinocandin-susceptible and -resistant invasive candidiasis at equivalent micafungin human-exposure levels and CD101 anticipated human-exposure levels in mice.
Copies of all Cidara posters will be available at http://www.cidara.com following the ICAAC/ICC meeting.
About Cidara Therapeutics
Cidara is a clinical stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives for the treatment of diseases that are inadequately addressed by current standard-of-care therapies. Cidara’s initial product portfolio comprises two formulations of the company’s novel echinocandin, CD101, for the treatment of serious fungal infections. CD101 IV is a long-acting therapy for the treatment and prevention of systemic fungal infections. CD101 Topical is for the treatment of vulvovaginal candidiasis (VVC) and recurrent VVC (RVVC), a prevalent mucosal infection. In addition, Cidara has developed a proprietary immunotherapy platform, Cloudbreak™, designed to create compounds that direct a patient’s immune cells to attack and eliminate pathogens that cause infectious disease. 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 effectiveness, safety, long-acting nature, anticipated human dosing and other attributes of CD101 IV and its potential to treat infections, the incidence of fungal infections, and the effectiveness and treatment protocols for competitive therapies. 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 documents most recently filed with the United States Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, under the heading “Risk Factors.” 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.
Source: Cidara Therapeutics, Inc.