Brexafemme (ibrexafungerp) partners GSK and Scynexis have worked out their quarrel related to a clinical trial that was previously put on hold, leaving Scynexis with a $22 million payout.
Per the resolution, Scynexis will wind down its phase 3 MARIO study of Brexafemme in invasive candidiasis, the company said in an Oct. 15 press release. Besides the $22 million sum, the company stands to receive an additional $2.3 million related to trial wind-down activities, Scynexis said.
Scynexis will not receive any further milestone payments from GSK in relation to the MARIO study.
GSK is still on board with its Scynexis collaboration and plans to commercialize Brexafemme in its approved indications of vulvovaginal candidiasis (VVC) and refractory vulvovaginal candidiasis (rVVC), according to Scynexis. After Scynexis transfers the drug’s regulatory application to GSK by the end of this year, the British company hopes to begin discussions with the FDA on a relaunch of the medicine.
“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,” Scynexis CEO David Angulo, M.D., said in the release.
GSK and Scynexis shook hands on a Brexafemme licensing deal in early 2023. Later that year, GSK found that the equipment used to make the drug was also used to produce a beta-lactam substance, which can trigger allergies in some people. Scynexis then recalled the drug due to the potential for cross-contamination.
When the FDA lifted a clinical trial hold after 19 months this May, Scynexis quickly moved to resume the delayed study. GSK, for its part, wanted its partner to terminate the trial.
GSK’s objections were still in play when Scynexis began dosing patients in the re-enrolled study, triggering a $10 million milestone payment under the original contract. GSK disputed the milestone but said it remained committed to marketing the drug.
Brexafemme was approved in 2021 for VVC, bringing a new class of antifungal drugs to the indication. GSK paid Scynexis $90 million upfront to get in on the drug, but later cut down its milestone obligations as part of a 2024 deal amendment.