An agreement between pharmaceutical company Scynexis and the U.S. Food and Drug Administration (FDA) was reached under a special protocol assessment (SPA) on the details of the CANDLE (Conditions Affecting Neurocognitive Development and Learning in Early childhood) study for Oral Ibrexafungerp.
The medicine will be used to for the prevention of vulvovaginal candidiasis, (VVC) which currently has no FDA-approved therapies. The SPA agreement means the FDA believes the Phase 3 protocol design is enough to address efficacy objectives. Within the CANDLE study is a sub-study addressing patients who did not respond to multiple doses of fluconazole.
"We have been highly encouraged by the early clinical safety and efficacy results observed with oral ibrexafungerp in VVC patients, and we look forward to further elucidating its potential for the prevention of recurrent VVC,” Ryan Sobel, M.D., clinical assistant professor at Jefferson Health in Philadelphia, founder of the Center for Vaginal Health and an investigator in Scynexis' Phase 3 VVC program, said in a press release. “Together with the two ongoing Phase 3 clinical trials of oral ibrexafungerp for the treatment of VVC, the CANDLE study may provide clinicians with additional evidence of the potential of this novel agent to effectively treat VVC and prevent recurrence of the infection, addressing an ongoing unmet need for this patient population."
The multi-center, randomized, double-blind, placebo-controlled Phase 3 CANDLE study will be enrolling females 12 years and older during this quarter. The primary goal of the study is to determine the percentage of patients with no reoccurring VVC after 24 weeks.
"VVC is a prevalent and serious condition with significant morbidity, yet there is only one oral option available to treat acute episodes and no product approved for the prevention of recurrent VVC," Marco Taglietti, M.D., president and chief executive officer of Scynexis, said in the release. "This SPA agreement for the Phase 3 CANDLE study design clarifies the regulatory path to approval in recurrent VVC. The results from this study and the two ongoing acute VVC Phase 3 studies can support the positioning of oral ibrexafungerp as the leading agent for both treatment of VVC and prevention of recurrent VVC. Moreover, a nested sub-study in the CANDLE study will provide valuable data assessing the efficacy of ibrexafungerp in VVC patients where even multiple doses of fluconazole failed to sufficiently resolve the acute infection, further differentiating ibrexafungerp from currently available treatments."
