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Abstract
Discussion Forum (0)
Introduction: Non-albicans Candida species vaginitis is difficult to treat because of their intrinsic and acquired resistance to the azole class. Ibrexafungerp (IBX) is a novel oral triterpenoid antifungal in registration for the treatment of vulvovaginal candidiasis (VVC). IBX is fungicidal with broad activity against Candida spp., including fluconazole-resistant strains. We present an analysis of outcomes from patients with non-albicans Candida VVC from VANISH-303 study.
Methods: VANISH-303 is a U.S. multicenter, randomized, double-blind study, where patients were randomized to oral IBX 300 mg BID for one-day or matching placebo in a 2:1 ratio. Eligible patients had to present with an episode of VVC with Vaginal Signs and Symptoms (S&S) score ≥4. Primary efficacy population was the modified-intent-to-treat (mITT), patients with culture confirmed Candida spp. infection at baseline who received at least one dose of study treatment. The primary endpoint was Clinical Cure, defined as complete resolution (score of 0) of all S&S at the Day-10 test-of-cure (TOC) visit.
Results: VANISH-303 study included 286 subjects in the mITT group with 188 in the IBX arm. Of these, 19 subjects in the IBX arm and 13 patients in the placebo arm had a non-albicans Candida isolate at baseline. Overall, the Clinical Cure at TOC for IBX was 50.5%, superior (p=0.001) to placebo, 28.6%. In the non-albicans Candida group the Clinical Cure at TOC was 47.7% for IBX and 30.8% for placebo.
Conclusion/Implications: This subset analysis shows that outcomes for IBX patients with non-albicans Candida VVC were similar to the total population in this study.
Methods: VANISH-303 is a U.S. multicenter, randomized, double-blind study, where patients were randomized to oral IBX 300 mg BID for one-day or matching placebo in a 2:1 ratio. Eligible patients had to present with an episode of VVC with Vaginal Signs and Symptoms (S&S) score ≥4. Primary efficacy population was the modified-intent-to-treat (mITT), patients with culture confirmed Candida spp. infection at baseline who received at least one dose of study treatment. The primary endpoint was Clinical Cure, defined as complete resolution (score of 0) of all S&S at the Day-10 test-of-cure (TOC) visit.
Results: VANISH-303 study included 286 subjects in the mITT group with 188 in the IBX arm. Of these, 19 subjects in the IBX arm and 13 patients in the placebo arm had a non-albicans Candida isolate at baseline. Overall, the Clinical Cure at TOC for IBX was 50.5%, superior (p=0.001) to placebo, 28.6%. In the non-albicans Candida group the Clinical Cure at TOC was 47.7% for IBX and 30.8% for placebo.
Conclusion/Implications: This subset analysis shows that outcomes for IBX patients with non-albicans Candida VVC were similar to the total population in this study.
Introduction: Non-albicans Candida species vaginitis is difficult to treat because of their intrinsic and acquired resistance to the azole class. Ibrexafungerp (IBX) is a novel oral triterpenoid antifungal in registration for the treatment of vulvovaginal candidiasis (VVC). IBX is fungicidal with broad activity against Candida spp., including fluconazole-resistant strains. We present an analysis of outcomes from patients with non-albicans Candida VVC from VANISH-303 study.
Methods: VANISH-303 is a U.S. multicenter, randomized, double-blind study, where patients were randomized to oral IBX 300 mg BID for one-day or matching placebo in a 2:1 ratio. Eligible patients had to present with an episode of VVC with Vaginal Signs and Symptoms (S&S) score ≥4. Primary efficacy population was the modified-intent-to-treat (mITT), patients with culture confirmed Candida spp. infection at baseline who received at least one dose of study treatment. The primary endpoint was Clinical Cure, defined as complete resolution (score of 0) of all S&S at the Day-10 test-of-cure (TOC) visit.
Results: VANISH-303 study included 286 subjects in the mITT group with 188 in the IBX arm. Of these, 19 subjects in the IBX arm and 13 patients in the placebo arm had a non-albicans Candida isolate at baseline. Overall, the Clinical Cure at TOC for IBX was 50.5%, superior (p=0.001) to placebo, 28.6%. In the non-albicans Candida group the Clinical Cure at TOC was 47.7% for IBX and 30.8% for placebo.
Conclusion/Implications: This subset analysis shows that outcomes for IBX patients with non-albicans Candida VVC were similar to the total population in this study.
Methods: VANISH-303 is a U.S. multicenter, randomized, double-blind study, where patients were randomized to oral IBX 300 mg BID for one-day or matching placebo in a 2:1 ratio. Eligible patients had to present with an episode of VVC with Vaginal Signs and Symptoms (S&S) score ≥4. Primary efficacy population was the modified-intent-to-treat (mITT), patients with culture confirmed Candida spp. infection at baseline who received at least one dose of study treatment. The primary endpoint was Clinical Cure, defined as complete resolution (score of 0) of all S&S at the Day-10 test-of-cure (TOC) visit.
Results: VANISH-303 study included 286 subjects in the mITT group with 188 in the IBX arm. Of these, 19 subjects in the IBX arm and 13 patients in the placebo arm had a non-albicans Candida isolate at baseline. Overall, the Clinical Cure at TOC for IBX was 50.5%, superior (p=0.001) to placebo, 28.6%. In the non-albicans Candida group the Clinical Cure at TOC was 47.7% for IBX and 30.8% for placebo.
Conclusion/Implications: This subset analysis shows that outcomes for IBX patients with non-albicans Candida VVC were similar to the total population in this study.
Phase 3 Oral Ibrexafungerp Study in Vulvovaginal Candidiasis (VANISH-303): Outcomes in Non-albicans Candida spp.
Dr. David Angulo Gonzalez
Abstract
Discussion Forum (0)
Introduction: Non-albicans Candida species vaginitis is difficult to treat because of their intrinsic and acquired resistance to the azole class. Ibrexafungerp (IBX) is a novel oral triterpenoid antifungal in registration for the treatment of vulvovaginal candidiasis (VVC). IBX is fungicidal with broad activity against Candida spp., including fluconazole-resistant strains. We present an analysis of outcomes from patients with non-albicans Candida VVC from VANISH-303 study.
Methods: VANISH-303 is a U.S. multicenter, randomized, double-blind study, where patients were randomized to oral IBX 300 mg BID for one-day or matching placebo in a 2:1 ratio. Eligible patients had to present with an episode of VVC with Vaginal Signs and Symptoms (S&S) score ≥4. Primary efficacy population was the modified-intent-to-treat (mITT), patients with culture confirmed Candida spp. infection at baseline who received at least one dose of study treatment. The primary endpoint was Clinical Cure, defined as complete resolution (score of 0) of all S&S at the Day-10 test-of-cure (TOC) visit.
Results: VANISH-303 study included 286 subjects in the mITT group with 188 in the IBX arm. Of these, 19 subjects in the IBX arm and 13 patients in the placebo arm had a non-albicans Candida isolate at baseline. Overall, the Clinical Cure at TOC for IBX was 50.5%, superior (p=0.001) to placebo, 28.6%. In the non-albicans Candida group the Clinical Cure at TOC was 47.7% for IBX and 30.8% for placebo.
Conclusion/Implications: This subset analysis shows that outcomes for IBX patients with non-albicans Candida VVC were similar to the total population in this study.
Methods: VANISH-303 is a U.S. multicenter, randomized, double-blind study, where patients were randomized to oral IBX 300 mg BID for one-day or matching placebo in a 2:1 ratio. Eligible patients had to present with an episode of VVC with Vaginal Signs and Symptoms (S&S) score ≥4. Primary efficacy population was the modified-intent-to-treat (mITT), patients with culture confirmed Candida spp. infection at baseline who received at least one dose of study treatment. The primary endpoint was Clinical Cure, defined as complete resolution (score of 0) of all S&S at the Day-10 test-of-cure (TOC) visit.
Results: VANISH-303 study included 286 subjects in the mITT group with 188 in the IBX arm. Of these, 19 subjects in the IBX arm and 13 patients in the placebo arm had a non-albicans Candida isolate at baseline. Overall, the Clinical Cure at TOC for IBX was 50.5%, superior (p=0.001) to placebo, 28.6%. In the non-albicans Candida group the Clinical Cure at TOC was 47.7% for IBX and 30.8% for placebo.
Conclusion/Implications: This subset analysis shows that outcomes for IBX patients with non-albicans Candida VVC were similar to the total population in this study.
Introduction: Non-albicans Candida species vaginitis is difficult to treat because of their intrinsic and acquired resistance to the azole class. Ibrexafungerp (IBX) is a novel oral triterpenoid antifungal in registration for the treatment of vulvovaginal candidiasis (VVC). IBX is fungicidal with broad activity against Candida spp., including fluconazole-resistant strains. We present an analysis of outcomes from patients with non-albicans Candida VVC from VANISH-303 study.
Methods: VANISH-303 is a U.S. multicenter, randomized, double-blind study, where patients were randomized to oral IBX 300 mg BID for one-day or matching placebo in a 2:1 ratio. Eligible patients had to present with an episode of VVC with Vaginal Signs and Symptoms (S&S) score ≥4. Primary efficacy population was the modified-intent-to-treat (mITT), patients with culture confirmed Candida spp. infection at baseline who received at least one dose of study treatment. The primary endpoint was Clinical Cure, defined as complete resolution (score of 0) of all S&S at the Day-10 test-of-cure (TOC) visit.
Results: VANISH-303 study included 286 subjects in the mITT group with 188 in the IBX arm. Of these, 19 subjects in the IBX arm and 13 patients in the placebo arm had a non-albicans Candida isolate at baseline. Overall, the Clinical Cure at TOC for IBX was 50.5%, superior (p=0.001) to placebo, 28.6%. In the non-albicans Candida group the Clinical Cure at TOC was 47.7% for IBX and 30.8% for placebo.
Conclusion/Implications: This subset analysis shows that outcomes for IBX patients with non-albicans Candida VVC were similar to the total population in this study.
Methods: VANISH-303 is a U.S. multicenter, randomized, double-blind study, where patients were randomized to oral IBX 300 mg BID for one-day or matching placebo in a 2:1 ratio. Eligible patients had to present with an episode of VVC with Vaginal Signs and Symptoms (S&S) score ≥4. Primary efficacy population was the modified-intent-to-treat (mITT), patients with culture confirmed Candida spp. infection at baseline who received at least one dose of study treatment. The primary endpoint was Clinical Cure, defined as complete resolution (score of 0) of all S&S at the Day-10 test-of-cure (TOC) visit.
Results: VANISH-303 study included 286 subjects in the mITT group with 188 in the IBX arm. Of these, 19 subjects in the IBX arm and 13 patients in the placebo arm had a non-albicans Candida isolate at baseline. Overall, the Clinical Cure at TOC for IBX was 50.5%, superior (p=0.001) to placebo, 28.6%. In the non-albicans Candida group the Clinical Cure at TOC was 47.7% for IBX and 30.8% for placebo.
Conclusion/Implications: This subset analysis shows that outcomes for IBX patients with non-albicans Candida VVC were similar to the total population in this study.
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