Scynexis Inc. (SCYX), which is in exclusive license deal with GSK plc (GSK,GSK.L) for antifungal drug Brexafemme (ibrexafungerp tablets), said it is recalling the drug from the market and placing a temporary hold on clinical studies of ibrexafungerp, citing cross contamination concerns.<\/p>\n
In pre-market activity on Nasdaq, SCYNEXIS shares were losing around 4.1 percent.<\/p>\n
The company has put its ibrexafungerp trials on hold, including the Phase 3 MARIO study, until a mitigation strategy and a resupply plan are determined.<\/p>\n
The decision follows a recent review by GSK of the manufacturing process and equipment at the vendor that manufactures the ibrexafungerp drug substance.<\/p>\n
SCYNEXIS said it became aware that a non-antibacterial beta-lactam drug substance is manufactured using equipment common to the manufacturing process for ibrexafungerp.<\/p>\n
The company noted that current FDA guidance “recommends segregating the manufacture of beta-lactam compounds from other compounds since beta-lactam compounds have the potential to act as sensitizing agents that may trigger hypersensitivity or an allergic reaction in some people. In the absence of the recommended segregation, there is a risk of cross contamination.”<\/p>\n
Meanwhile, it is not known whether any ibrexafungerp has been contaminated with a beta-lactam compound and SCYNEXIS has not received reports of adverse events established to be due to the possible beta-lactam cross contamination.<\/p>\n
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