Company: SCYX
Filing Date: 2025-03-12
Form Type: 10-K
Source: 0000950170-25-038044
Chunk: 24

Company: SCYNEXIS INC
Filing Date: 2025-03-12
Form: 10-K
Item: Item 1
Chunk 24
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) of oral ibrexafungerp in combination with voriconazole in patients with IA was conducted. This study is a randomized, double-blind trial with the objective of assessing the safety and efficacy of oral ibrexafungerp in combination with voriconazole, compared to voriconazole alone. We completed the study with 22 patients enrolled and provided the final clinical study report to GSK in September 2024.

Treatment of VVC

We have completed the VANQUISH Phase 3b open-label trial (VANQUISH study) evaluating the safety and efficacy of ibrexafungerp in patients with complicated vulvovaginal candidiasis who failed to respond to treatment with fluconazole.  The VANQUISH study enrolled 150 complicated VVC patients who received 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).  We provided the final clinical study report to GSK in August 2024.

Key Development Milestones

We are seeking to achieve the following key near term milestones:

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•to lift the clinical hold placed on ibrexafungerp by the FDA to enable the resumption of enrollment in the MARIO study, a global Phase 3 study to evaluate ibrexafungerp as an oral step-down treatment for IC in the hospital setting; and

•to complete the Phase 1 study for SCY-247 to guide for next steps of clinical development.

Our Strategy 

Key elements of our strategy include:

•to leverage our strong scientific team to pursue the development of other internal proprietary compounds, including SCY-247; 

•to maximize ibrexafungerp’s value, in line with the GSK License Agreement, by delivering the results of completed and ongoing clinical trials under our responsibility enabling further expansion of indications including invasive fungal infections; and

•to assess external opportunities for in-licensing to expand our development pipeline and add products for commercialization.

Triterpenoid Antifungals 

The triterpenoid antifungals (the fungerps) are a novel antifungal class that act through the inhibition of the glucan synthase complex, an established target in ant