Cidara Therapeutics Inc (NASDAQ:CDTX) reported Monday that its lead antifungal drug candidate sailed through a mid-stage clinical study, sending shares in the junior biotech towards 13-month highs.
Shortly before the opening bell in New York, the stock was up 14% to US$9.
Met all primary endpoints
The San Diego-based group’s rezafungin acetate drug met all of its primary endpoints in the Phase II STRIVE trial – which pitted it against Merck & Co Inc’s (NYSE:MRK) caspofungin treatment.
Rezafungin was safe and well tolerated in patients with candidemia and/ or invasive candidiasis, while the data also showed evidence of the drug’s efficacy – i.e. not only as it is safe, but it is also effective.
At the moment, patients with a fungal infection have to take caspofungin once a day, but one of the key advantages of rezafungin is that it only needs to be taken once a week.
“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,” said president and chief executive Jeffrey Stein.
“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 III pivotal trials of rezafungin in treatment and prophylaxis.”
Speaking of the next stage, Cidara plans to kick off two late-stage studies in the middle of this year.