Rezafungin Safety + Efficacy in a Phase 2 Candidemia Trial
Grant M. Gallagher
Rezafungin appears safe and efficacious in a comparison with caspofungin. The novel antifungal could facilitate easier treatment courses for patients with candidemia or invasive candidiasis.
Rezafungin is a new echinocandin-class antifungal with promising pharmacokinetics and pharmacodynamics which could facilitate easier treatment courses for patients with candidemia or invasive candidiasis. According to results of a phase 2 trial, the treatment is safe and works.
The STRIVE study was a phase 2, double-blind, randomized trial comparing the safety and efficacy of rezafungin once per week with that of caspofungin once per day. Results were published in Oxford's Clinical Infectious Diseases journal.
In the trial, adult participants with mycological confirmation of candidemia and/or invasive candidiasis were randomized to 400 mg of rezafungin weekly, rezafungin 400 mg on week 1 followed by 200 mg per week, or caspofungin 70 mg followed by 50 mg daily for ≤ 4 weeks.
Efficacy assessments had 2 primary endpoints:
- overall cure: resolution of signs of candidemia/invasive candidiasis
- mycological eradication at day 14
As well as secondary endpoints:
- investigator-assessed clinical response at day 14
- 30-day all-cause mortality and time to negative blood culture.
Out of the 207 participants enrolled, 183 were placed in the microbiological intent-to-treat population (~21% IC).
Cure rates were 60.5% (46/76) for rezafungin 400 mg, 76.1% (35/46) for rezafungin 400/200 mg, and 67.2% (41/61) for caspofungin.
Investigator-assessed clinical cure rates were 69.7% (53/76) for rezafungin 400 mg, 80.4% (37/46) for rezafungin 400/200 mg, and 70.5% (43/61) for caspofungin.
30-day all cause mortality was 15.8% for rezafungin 400 mg, 4.4% for rezafungin 400/200 mg, and 13.1% for caspofungin.
Candidemia was cleared in 19.5 hours in rezafungin and 22.8 hours in caspofungin patients.
"No concerning safety trends were observed" authors add.
Contagion Connect Episode 7 - The ID Pipeline: Rezafungin & Antiviral Fc-Conjugates
Publication: April 2, 2020.
Podcast Description: Cidara Therapeutics is developing a new echinocandin called Rezafungin that's shown promise in clinical trials. Cidara is also developing a new anti-viral technology which isn't a vaccine, but could provide universal flu protection on a different basis.
We talked to CEO Jeff Stein, PhD, about these therapies.
After speaking with Dr. Stein, we hone in on Rezafungin in a chat with George Thompson, MD, associate professor of clinical medicine at the UC Davis School of Medicine.
Dr. Thompson is an infectious disease clinician and an expert in the mycology field. He was an investigator in Cidara’s phase two trial of Rezafungin and is involved in the currently being enrolled phase three trial.