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

GSK and Scynexis have reached a resolution in their dispute over the phase 3 MARIO study of antifungal drug Brexafemme (ibrexafungerp) in invasive candidiasis. The agreement involves a $22 million payment from GSK to Scynexis and the winding down of the clinical trial.

Settlement Details and Trial Wind-Down

Under the terms of the settlement, Scynexis will receive $22 million from GSK, with an additional $2.3 million allocated for trial wind-down activities. The agreement stipulates that Scynexis will not receive any further milestone payments related to the MARIO study.

David Angulo, M.D., CEO of Scynexis, expressed mixed feelings about the outcome: "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."

Brexafemme's Future and GSK's Commitment

Despite the trial's termination, GSK remains committed to its collaboration with Scynexis. The British pharmaceutical giant plans to commercialize Brexafemme in its approved indications of vulvovaginal candidiasis (VVC) and refractory vulvovaginal candidiasis (rVVC).

Scynexis is set to transfer the drug's regulatory application to GSK by the end of 2025. Following this transfer, GSK intends to initiate discussions with the FDA regarding the relaunch of Brexafemme, which was previously recalled due to potential cross-contamination concerns.

Background of the Dispute

The disagreement between GSK and Scynexis stemmed from the resumption of the MARIO study earlier this year. After the FDA lifted a 19-month clinical trial hold in May, Scynexis promptly restarted the study. However, GSK expressed a desire for its partner to terminate the trial.

The conflict escalated when Scynexis began dosing patients in the re-enrolled study, triggering a $10 million milestone payment under the original contract. GSK disputed this milestone but maintained its commitment to marketing the drug.

Brexafemme, approved in 2021 for VVC, represents a new class of antifungal drugs. GSK initially paid Scynexis $90 million upfront for licensing rights but later revised its milestone obligations in a 2024 deal amendment.