GSK and Scynexis Resolve Brexafemme Trial Dispute with $22M Settlement

GSK and Scynexis have reached an agreement to resolve their dispute over the phase 3 MARIO study of the antifungal medication Brexafemme (ibrexafungerp) in invasive candidiasis. The resolution includes a $22 million payment from GSK to Scynexis and marks a significant development in their ongoing collaboration.

Trial Wind-Down and Financial Details

Scynexis has agreed to wind down the MARIO study at GSK's request, following the lifting of an FDA clinical hold earlier this year. In addition to the $22 million settlement, Scynexis will receive an extra $2.3 million to cover trial wind-down activities. However, the company will not be eligible for any further milestone payments related to the MARIO study.

Despite this setback, GSK remains committed to its partnership with Scynexis and plans to move forward with the commercialization of Brexafemme in its approved indications of vulvovaginal candidiasis (VVC) and refractory vulvovaginal candidiasis (rVVC).

Regulatory Transfer and Relaunch Plans

As part of the agreement, Scynexis will transfer Brexafemme's regulatory application to GSK by the end of 2025. Following this transfer, GSK intends to initiate discussions with the FDA regarding the potential relaunch of the medication.

David Angulo, M.D., CEO of Scynexis, expressed mixed feelings about the resolution, stating, "While disappointed that the MARIO study will not continue, we're pleased to have resolved this disagreement with GSK and that it remains committed to relaunching Brexafemme."

Background and Future Outlook

The dispute between GSK and Scynexis stemmed from complications that arose after their initial licensing deal in early 2023. A recall of Brexafemme was initiated due to potential cross-contamination with beta-lactam substances, leading to a 19-month clinical trial hold by the FDA.

Brexafemme, approved in 2021 for VVC, represents a new class of antifungal drugs. Despite the current setback, both companies remain optimistic about the drug's future potential in treating fungal infections.