BioCryst Pharma's (BCRX) BCX4161 Put on Clinical Hold by FDA

November 27, 2012 6:09 AM EST
On November 20, 2012, BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) had a teleconference with the U.S. Food and Drug Administration (FDA) regarding the Investigational New Drug (IND) application for BCX4161. During the call, FDA informed the Company that they were applying GMP manufacturing standards to the process of compounding BCX4161 capsules at the clinical site to be used for oral dosing studies. As a consequence, the BCX4161 IND has been placed on clinical hold. The practice of compounding drug product at clinical sites is not uncommon in Phase 1 studies. BioCryst had proposed to administer hard gel capsules containing formulated drug solution compounded at the clinical site.

The FDA will provide a letter within 30 days outlining the reasons for the clinical hold and the information required to have the hold removed. The Company had previously guided the initiation of Phase 1 testing in the United States before the end of 2012. The Company now estimates that Phase 1 testing of BCX4161 will be delayed approximately three months.

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