Scynexis has initiated a recall of antifungal drug, Brexafemme, licensed to GSK, due to concerns raised during GSK's review of the manufacturing process.
In an SEC filing, Scynexis explained that under the review, GSK found that the same equipment used for manufacturing Brexafemme (ibrexafungerp) was also employed in producing a non-antibacterial beta-lactam drug substance. Beta-lactam compounds have the potential to act as sensitizing agents, which could potentially trigger hypersensitivity or allergic reactions in certain individuals. As per the current FDA guidance, it is recommended to segregate the manufacturing of beta-lactam compounds from other substances to mitigate the risk of cross-contamination.
According to Scynexis, no confirmation was found that the ibrexafungerp drug product had been contaminated with a beta-lactam compound and the company has not received any reports of adverse events attributed to potential beta-lactam cross-contamination.
However, "in light of this risk and out of an abundance of caution" — and following a recommendation from GSK — Scynexis is recalling the tablets from the market and placing a temporary hold on clinical studies of ibrexafungerp, including the phase 3 MARIO study, pending a "mitigation strategy and a resupply plan."
GSK licensed the drug, a treatment for vulvovaginal candidiasis, from Scynexis in March 2023. In exchange for its only marketed product, the New Jersey-based Scynexis received an upfront payment of $90 million, plus additional potential milestone-based payments totaling $503 million. Half of those milestone payments hinge on development, regulatory and commercial milestones in the invasive candidiasis indication.