Biocryst ends $234.8 million Phase III flu trial in disapppointment
Difference between peramivir and control groups for the primary endpoint was small, and company doesn't expect to continue development for U.S. registration
RESEARCH TRIANGLE PARK, N.C.—With the difference between peramivir and control groups for theprimary endpoint small, BioCryst Pharmaceuticals Inc. has announced completion of the planned interim analysis of the peramivirPhase III trial in patients admitted to the hospital with seriousinfluenza. The company also noted that the recalculated sample size was "greaterthan the predefined futility boundary of 320 subjects" and, based on thisinformation, the independent data monitoring committee (DMC) recommendedthat the study be terminated for futility.
No unexpected adverse eventswere identified and the DMC expressed no concerns about the safety ofperamivir.
"The goal of this analysis was to reassess the sample size required forthe trial, and to make adjustments to the study if necessary. Based onthe DMC recommendation, we have suspended enrollment of patients in thetrial," said Dr. William P. Sheridan, senior vice president and chief medical officer of BioCryst Pharmaceuticals. "We are proceeding with afull analysis of unblinded data from the trial, and a final decisionwill be made following completion of the analysis and furtherdiscussions with our development partners; however, it is unlikely thatperamivir development for U.S. registration will continue."
Peramivir is described by the company as "a potent, intravenously administered investigationalanti-viral agent that rapidly delivers high plasma concentrations to thesites of infection." Discovered by BioCryst, peramivir is intended to inhibit theinteractions of influenza neuraminidase, an enzyme that is said to be critical tothe spread of influenza within a host. In laboratory tests, peramivirhas shown activity against multiple influenza strains, includingpandemic H1N1 swine origin flu viral strains.
