Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today announced data from the company's Phase 1 multiple ascending dose clinical trial of its antifungal drug candidate, CD101 IV, in healthy volunteers. CD101 IV is a novel, long-acting echinocandin that Cidara is developing for the treatment and prevention of serious, invasive fungal infections, including candidemia and invasive candidiasis.
Key results of the multiple ascending dose (MAD) trial for CD101 IV reinforce the compound's excellent safety and tolerability: CD101 was well tolerated systemically across the entire dose range; no serious or severe adverse events were seen. No clinical chemistry or hematology safety concerns were observed at any dose. All patients completed dosing in this multiple dose study.
"We are extremely encouraged by the Phase 1 multiple ascending dose study-data, which are consistent with the results of the single ascending dose study and thereby reinforce that CD101 IV is very well tolerated across a range of doses designed to provide high exposures," said Jeff Stein, Ph.D., president and CEO of Cidara. "These data provide us with further confidence that CD101 IV can be developed as a safe, high-exposure, once-weekly treatment for severe fungal infections. We are now poised to advance into patients with candidemia in a comparator-controlled phase 2 trial in the coming months."
The CD101 IV Phase 1 MAD trial was a randomized, double-blind, placebo-controlled, dose-escalation study designed to establish the safety, tolerability, and pharmacokinetics of multiple intravenous doses of CD101 IV. The study enrolled 24 healthy adult volunteers in dose cohorts of 100 mg, 200 mg, and 400 mg. In each cohort of eight subjects, six subjects received CD101 IV and two subjects received placebo. The 100mg and 200mg cohorts each received two doses of CD101 IV dosed one week apart, while the 400mg cohort received three once-weekly doses. Subjects were monitored for safety assessments and pharmacokinetics for three weeks following infusion.
Based on the results from the single and multiple ascending dose studies, Cidara plans to initiate a Phase 2 trial of CD101 IV in candidemia in the first half of 2016. More information about the Phase 1 trials for CD101 IV is available on ClinicalTrials.gov using the study codes for the SAD trial: NCT02516904 and the MAD trial: NCT02551549.
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. CD101 IV is a long-acting therapy for the treatment and prevention of serious, invasive 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.
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 IV and its potential to treat infections, the incidence of fungal infections, and the effectiveness of 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 Form 10-Q filed with the United States Securities and Exchange Commission (SEC), 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.