Cidara Therapeutics’ (NASDAQ:CDTX) suggested future Phase III trial design investigating intravenous (IV) CD101 for candidiasis is well-designed to demonstrate noninferiority compared with standard of care (SOC), experts said. CD101’s superior dosing schedule is likely to see it take a significant slice of the existing antifungal market, most added.
Whilst some agreed on the details of the future Phase III trial’s design, the study’s size had two experts noting that it may be too small. On market traction, one expert said the once-weekly dosing advantage may not be convincing enough to supplant SOC given a potential high price for CD101. Supplementary investigations in specific subpopulations and reducing dosing further to a single administration could be valuable for market edge, some added.
Cidara plans a global Phase III in YE17 or 1H18, this news service reported on November 2015. The ongoing Phase II candidemia trial (NCT02734862) is expected to read out in 4Q17, this news service reported 28 February.
The Phase II is expected to show comparable efficacy/safety with other echinocandins, which are the SOC, like Merck’s (NYSE:MRK) Cancidas (caspofungin), Astellas’ (TYO:4503) Mycamine (micafungin) and Pfizer's (NYSE:PFE) Eraxis (anidulafungin). One analyst report places sales of IV CD101 at USD 490m by 2025.