Silver stain (GMS) showing psuedohyphae and budding yeast forms in candidiasis infection. Credit: Yale Rosen.

Cidara Therapeutics has announced that its antifungal candidate rezafungin met all efficacy, safety, and tolerability measures in part B of Phase II STRIVE (STRIVE B) clinical trial involving candidemia and/or invasive candidiasis patients.

The company is developing rezafungin as a once-weekly, first-line treatment for serious invasive fungal infections. The drug candidate is also meant for the prevention of such infections.

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During STRIVE B, once-weekly rezafungin was compared to once-daily caspofungin. The trial’s microbiological intent-to-treat (mITT) population had 91 patients.

A regimen involving 400mg rezafungin for two to four weeks was later changed to 400mg during the first week, followed by 200mg up to week four. This new dosing regimen has been selected for the therapeutic’s Phase III trial.

The STRIVE B study’s efficacy measures included clearance of Candida from the blood or other usually sterile sites, resolution of systemic signs of Candida infection, clinical response, and overall survival.

According to top-line data, the 400mg/200mg regimen of Cidara’s drug led to numerically improved outcomes across all efficacy measures, compared to caspofungin.

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An analysis of results from STRIVE parts A and B showed meaningful improvement in outcomes with the same dosing regimen, versus caspofungin, across all efficacy endpoints.

Cidara noted that efficacy comparisons in the trial are directional, as STRIVE is not designed to evaluate statistically significant differences or non-inferiority.

In STRIVE B, the investigational drug was found to be generally safe and well-tolerated.

Treatment-emergent adverse events (TEAEs) were reported in most patients, but study drug-related adverse events were substantially lower, the company said.

Cidara Therapeutics president and CEO Jeffrey Stein said: “Rezafungin has the potential to be the first safe and effective once-weekly, first-line treatment option for patients with difficult-to-treat and deadly invasive Candida infections, and we believe this trial moves us one step closer to market.

“Additionally, the combined STRIVE A and B results are aligned with our expectations for the ongoing ReSTORE Phase III trial, from which the data, if positive, will be used to support our NDA.”

Cidara announced positive top-line data from STRIVE A in March last year.