Investigational antifungal fosmanogepix safe, well tolerated in small study
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The investigational antifungal fosmanogepix was found to be safe and well tolerated with a high level of treatment success in patients with candidemia, according to data from a small open-label study presented at IDWeek.
The study, which focused on more resistant Candida isolates, was prompted by “the need for antifungal agents with greater activity vs. resistant Candida isolates, available in both IV and oral” formulations, Peter G. Pappas, MD, professor of medicine at the University of Alabama at Birmingham, explained to Healio.
Fosmanogepix (FMGX, Amplyx) is a first-in-class antifungal agent with broad-spectrum activity against yeasts, molds and dimorphic fungi, including fungi resistant to other antifungal agents, according to the abstract.
Pappas and colleagues conducted a global, multicenter, open-label, noncomparative study to evaluate the safety and efficacy of the investigational antifungal for first-line treatment of candidemia. According to the study, patients were eligible if they had a recent diagnosis of candidemia, defined as positive blood culture for Candida species within 96 hours before study entry with 2 days or less of prior antifungal treatment.
During the study, patients were treated with FMGX for up to 14 days 1,000 mg IV twice a day for 1 day, then 600 mg IV once a day for at least 2 days, followed by either 600 mg IV once a day or 700 mg orally once a day. Short-term fluconazole could follow if treatment was required beyond 14 days, according to the abstract.
In all, 21 subjects were enrolled in the study and 20 were included in the modified intention to treat population. All participants received IV FMGX; 48% received oral FMGX.
According to the study, the success rate was 80% and survival at day 30 was 85%, although researchers noted that three of the deaths that occurred were not related FMGX.
Pappas said the study demonstrated “enough positive data to justify developing a large phase 3 comparative trial.”
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Pappas PG, et al. Oral abstract 147 Presented at: IDWeek; Oct. 21-25, 2020 (virtual meeting).
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