Scynexis Recalls GSK- Licensed Ibrexafungerp Tablets, Halts Trials On Contamination Concerns
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.
In pre-market activity on Nasdaq, SCYNEXIS shares were losing around 4.1 percent.
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.
The decision follows a recent review by GSK of the manufacturing process and equipment at the vendor that manufactures the ibrexafungerp drug substance.
SCYNEXIS said it became aware that a non-antibacterial beta-lactam drug substance is manufactured using equipment common to the manufacturing process for ibrexafungerp.
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.”
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.
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