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SCYNEXIS Announces Initiation of New Phase 3b Study (VANQUISH) to Evaluate Oral Ibrexafungerp as a Treatment for Complicated Vulvovaginal Candidiasis (VVC) in Patients Who Failed to Respond to Treatment with Fluconazole
JERSEY CITY, N.J., June 23, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and
About this update from Scynexis, Inc.
[{"type":"text","content":"JERSEY CITY, N.J., June 23, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the initiation and first patient enrolled in a new Phase 3b, open-label, multicenter study (VANQUISH) to evaluate the efficacy, safety and tolerability of oral ibrexafungerp as a treatment for complicated vulvovaginal candidiasis (VVC) in patients who have failed treatment with fluconazole, based on mycological and clinical outcomes. The VANQUISH study will enroll approximately 150 difficult-to-treat complicated VVC patients who will receive 600 mg of oral ibrexafungerp for one, three or seven consecutive days determined by their underlying complicating condition including immunocompromised state. Complicated patients include patients with recurrent VVC, those with VVC caused by non-albicans Candida species and those with diabetes, immunocompromising conditions (e.g., HIV), or immunosuppressive therapy (e.g., corticosteroids). “After seeing the strong positive results of patients in the CANDLE Sub-study who had failed fluconazole and the refractory or relapsed VVC cases in our ongoing FURI study, we decided to conduct additional research to explore the efficacy of ibrexafungerp specifically in patients with the most challenging yeast infection cases that have not responded to azole treatments,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “This is another step in our efforts to advance this important non-azole antifungal treatment for VVC that provides an alternative for women with severe, difficult-to-treat fungal infections. Once completed, we believe the results of this study could further demonstrate ibrexafungerp’s ability to treat multiple types of complicated cases.” Of the 14 patients in the Phase 3 open-label, single-arm FURI study (NCT03059992) with refractory or relapsed cases of VVC treated with ibrexafungerp, 10 (71.4%) had successful clinical outcomes as judged by an independent Data Review Committee. In the nested sub-study of the CANDLE Phase 3 trial, 24 patients who failed to respond to the initial three-day regimen of fluconazole received a one-day open-label treatment course of ibrexafungerp (300 mg BID), and 71% successfully achieved a significant re...