Rezafungin -New antifungal shows promise in phase 2 STRIVE trial

Cidara Therapeutics, a Biotechnology company has reported positive topline results from a phase 2 trial of it antifungal candidate rezafungin.

According to a company press release, there are positive topline results from Part B of the global Phase 2 STRIVE trial evaluating the company’s lead antifungal candidate rezafungin. In the STRIVE B trial, rezafungin met all of its objectives for efficacy, safety, and tolerability in the treatment of patients with candidemia and/or invasive candidiasis. Rezafungin is a novel echinocandin antifungal being developed as a once-weekly therapy for the first-line treatment and prevention of serious invasive fungal infections. The objective of the trial, which included 91 patients in the microbiological intention-to-treat population, was to compare the efficacy and safety of rezafungin administered once-weekly versus caspofungin dosed daily. Efficacy measures included clearance of Candida from the blood or other normally sterile sites, resolution of systemic signs of infection, investigator assessment of clinical response, and overall survival.

The results have shown that patients treated with rezafungin had numerically improved outcomes compared to caspofungin across all efficacy measures, and was generally safe and well-tolerated.

While the difference in outcomes for 400 mg/200 mg are encouraging, and the 400 mg/400 mg findings are consistent with comparator results, the size of the individual trial cohorts precludes any other conclusions pending a full assessment of trial data.

There were no unanticipated or concerning adverse event trends among STRIVE B trial participants. The top-line results indicate that rezafungin appeared to be generally safe and well-tolerated at both dosing regimens. As expected, and observed in STRIVE A, treatment-emergent adverse events (TEAEs) in the study population were observed in most patients, though study drug-related adverse events were substantially lower, with a frequency of 6.5 percent, zero percent and 14.7 percent in the 400 mg/400 mg, 400 mg/200 mg, and caspofungin groups respectively.

"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," said Cidara president and chief executive officer Jeffrey Stein, Ph.D.

The FDA has designated rezafungin as a Qualified Infectious Disease Product and granted it Fast Track status for the treatment of candidemia and invasive candidiasis.