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Cidara Therapeutics Presents Results from Key Studies Evaluating Its Novel Echinocandin CD101 at ICAAC/ICC 2015
– 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 –
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
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
“Current antifungal standards of care, including first-generation
echinocandins, have multiple limitations, including inconvenient daily
IV dosing and dose-limiting toxicities,” said
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.
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
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