SCYNEXIS has reported encouraging outcomes from a Phase I clinical trial of SCY-247, a second-generation triterpenoid antifungal being developed to treat and prevent invasive fungal infections.
This compound presents promising therapeutic benefits in both oral and intravenous (IV) forms.
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SCYNEXIS president and CEO David Angulo said: “We are pleased by the favourable results from this Phase I study demonstrating that orally administered SCY-247 can achieve target exposures for efficacy with favourable tolerability.
“We also observed that orally administered SCY-247 was able to achieve target exposures for invasive fungal disease at doses lower than our first generation fungerp, which may translate to a tolerability advantage.”
The trial assessed the pharmacokinetics, safety and tolerability of SCY-247, administered orally to healthy subjects.
Single ascending doses ranging from 50mg to 900mg, as well as multiple ascending doses of 50mg to 300mg were given once daily for seven days.
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By GlobalDataEach dose level involved eight subjects, with six receiving SCY-247 and two given matching placebo.
In total, 66 subjects received SCY-247 and 22 were given a placebo.
SCY-247 demonstrated good tolerability across all assessed cohorts, with no reports of serious or severe treatment-emergent adverse events (TEAEs).
The occurrence of TEAEs was observed to be low and showed no dose-dependent relationship, with all reported events classified as mild or moderate with regard to severity.
One subject notably withdrew from the trial because of an adverse event that was considered unrelated to the trial drug.
The most frequently reported adverse events included headaches that were mild to moderate and occurred in 16.7% of subjects receiving SCY-247 against 4.5% in the placebo group.
Additionally, diarrhoea was reported by 9% of subjects in both groups.
SCY-247 demonstrated generally dose-proportional pharmacokinetics after both single and multiple oral doses. The pharmacokinetic, safety and tolerability profile observed indicate support for the therapy’s ongoing clinical development.
