Rezafungin for candidemia, invasive candidiasis succeeds in phase II trial
The novel echinocandin rezafungin (RZF) appears to be effective against candidemia and invasive candidiasis (IC), with a favourable safety profile, according to the results of the phase II STRIVE trial.
STRIVE randomly assigned 207 adults with systemic signs and mycological confirmation of candidemia and/or IC to one of the following treatment arms: (1) RZF 400 mg once weekly, (2) RZF 400 mg at the first week then 200 mg weekly thereafter (400/200 mg), and (3) caspofungin (CAS) 70 mg as a loading dose followed by 50 mg daily for ≤4 weeks once daily.
Of the patients, 183 had documented Candida infection and were included in the microbiological intent-to-treat population. The species isolated at baseline were mostly Candida albicans (49.7 percent), followed by Candida glabrata (20.2 percent), Candida parapsilosis (15.3 percent), and Candida tropicalis (12.0 percent).
At day 14, overall cure rates were 60.5 percent (46/76) with RZF 400 mg, 76.1 percent (35/46) with RZF 400/200 mg, and 67.2 percent (41/61) with CAS. The respective investigator-assessed clinical cure rates were 69.7 percent (53/76), 80.4 percent (37/46), and 70.5 percent (43/61).
The 30-day all-cause mortality was 15.8 percent with RZF 400 mg, 4.4 percent with RZF 400/200 mg, and 13.1 percent with CAS.
Clearance of infection occurred within 19.5 hours in the combined RZF group and within 22.8 hours in the CAS group.
No concerning safety trends emerged. All-cause mortality through follow-up (days 45–52 for candidemia only or days 52–59 for IC, with or without candidemia) was 15.2 percent (21/138) with RZF and 18.8 percent (13/69) with CAS.