Title : A randomized phase 3 clinical study to evaluate the efficacy and safety of SHR8008 (oteseconazole) vs. fluconazole in subjects with vulvovaginal candidiasis (VVC)
Abstract:
Background
VIVJOA® (oteseconazole) is approved in the United States to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC). A Phase 3 study was conducted in China by Jiangsu Hengrui Pharmaceuticals Co. Ltd. to evaluate the efficacy and safety of SHR8008 (oteseconazole) versus fluconazole in subjects with VVC.
Methods
Enrolled subjects presented with a diagnosis of VVC at screening, including a composite signs and symptoms score of ≥ 7, with a positive potassium hydroxide or Gram stain. Subjects meeting all study eligibility criteria were randomized in a 1:1 ratio to received SHR8008 (oteseconazole) capsules (600mg on Day 1, 450mg on Day 2) or the current standard of care, fluconazole (150mg on Day 1, and 150mg on Day 4). Subjects returned to the study site on Day 14 and Day 28.
The primary endpoint evaluated therapeutic cure of VVC, defined as the absence of signs and symptoms of VVC together with a negative culture for Candida species in the mITT population on Day 28. A secondary endpoint also evaluated therapeutic cure on Day 14. The in vitro drug susceptibility and MIC results were also determined.
Results
Baseline demographics and characteristics were similar between treatment groups. A total of 322 subjects were randomized. In the mITT population, therapeutic cure at Day 28 was significantly higher in the SHR8008 (oteseconazole) group than in the fluconazole group (66.88% vs. 45.91%), P = 0.0002. Mycological cure at Day 28 was higher in the SHR8008 (oteseconazole) group than in the fluconazole group (82.50% vs. 59.12%), P < 0.0001.
Susceptibility analysis indicated that MIC's of SHR8008 (oteseconazole) were lower than those of fluconazole when screened against most Candida strains.
All collected C. albicans and C. glabrata isolates remained sensitive to SHR8008 (oteseconazole), whereas > 50% of isolates were either resistant or demonstrated dose dependent sensitivity to fluconazole.No clinically significant treatment-related impact on vital signs, physical examinations, ECG, or laboratory tests were observed.
Conclusion
Data from this Phase 3 clinical study suggests SHR8008 (oteseconazole) is safe and more effective than the current standard-of-care, fluconazole, in treating VVC.
Audience Take Away:
- Many women are affected by vaginal fungal infections, also called yeast infections. SHR8008 (oteseconazole) has been developed in clinical studies and may provide an effective treatment option for fungal infections.
- Vulvovaginal Candidiasis (VVC) is typically treated with a single dose or short treatments of either topical or oral azole antifungals. Fluconazole remains the current standard of care, however, drug resistance and safety liabilities are associated with its use. Data from this phase 3 clinical study suggests SHR8008 (oteseconazole) is safe and more effective in treating VVC.
- SHR8008 (oteseconazole) has demonstrated greater potency against Candida species, including azole resistant species, than fluconazole.
