Multiple Ascending Dose Study-Results Reinforce Excellent Safety and Tolerability
SAN DIEGO, CA, USA I January 11, 2016 I 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.
SOURCE: Cidara Therapeutics
Post Views: 141
Multiple Ascending Dose Study-Results Reinforce Excellent Safety and Tolerability
SAN DIEGO, CA, USA I January 11, 2016 I 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.
SOURCE: Cidara Therapeutics
Post Views: 141
