Cidara Therapeutics Inc. (NASDAQ: CDTX) shares took a big step back on Monday, despite the firm reporting positive midstage results. Specifically, Cidara reported positive topline results from its Phase 2 Strive clinical trial of its lead antifungal candidate rezafungin acetate.
The trial met all of its primary objectives, as once-weekly intravenous dosing of rezafungin was observed to be generally well tolerated and safe in patients with candidemia and invasive candidiasis.
The data also showed evidence of the efficacy of rezafungin, which was defined in the trial by clearance of Candida from the blood or other normally sterile sites, resolution of signs related to the infection, investigator assessment of clinical response and overall survival.
Ultimately, these results will enable Cidara to advance its planned Phase 3 pivotal trials in the treatment of candidemia and invasive candidiasis and the prevention (prophylaxis) of invasive fungal infections in 2018.
Jeffrey Stein, Ph.D., president and CEO of Cidara, commented:
We extend sincere thanks to our STRIVE participants, investigators and their site staff for their dedication and execution of this trial. This is the first time that any antifungal has shown the potential to be a safe and effective once-weekly treatment option for patients with difficult-to-treat and deadly invasive Candida infections, which may enable patients to leave the hospital earlier, saving money and improving care. It is especially encouraging to note the consistent trends in relative outcomes improvement among patients on the rezafungin 400/200 regimen as compared to those on the comparator caspofungin. With these data in hand, we can confidently select the dosing regimens for our two upcoming Phase 3 pivotal trials of rezafungin in treatment and prophylaxis.
Shares of Cidara were last seen down more than 24% at $5.98, with a consensus analyst price target of $14.06 and a 52-week range of $5.60 to $8.80.