BioCryst Pharmaceuticals, Inc. Announces Preliminary Phase III Trial Results for Influenza Neuraminidase Inhibitor, Peramivir
BIRMINGHAM, Ala., June 25 /PRNewswire-FirstCall/-- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX - News) today announced preliminary Phase III clinical trial data for peramivir, an investigational oral influenza neuraminidase inhibitor designed to treat and prevent influenza. Initial findings from the Phase III trial for the treatment of influenza A and B demonstrated no statistically significant difference in the primary efficacy endpoint -- the length of time from the first dose to the onset of clinically significant relief of influenza symptoms -- between groups treated with peramivir and groups treated with placebo (p=0.17). Based on these data, BioCryst has decided to discontinue the development of peramivir.
The objective of the Phase III trial was to assess the efficacy and safety of peramivir for the treatment of acute influenza A and influenza B infections in otherwise healthy adults. A total of 1,246 patients were randomized to one of three treatment groups over four flu seasons in Europe, the Southern Hemisphere and the United States, and 694 patients were evaluable based on having laboratory-confirmed influenza virus infection. Peramivir, administered once-a-day over five consecutive days at the standard dose (800mg per day) or loading dose (800mg on day one, followed by 400mg per day on days 2-5) showed a 0.64 and 0.53 day reduction, respectively, in the median time to improvement in influenza-infected subjects compared to subjects receiving placebo. Peramivir was well tolerated at both doses studied.
"Although we are disappointed with these results, we are fortunate to have resources that will allow us to focus on our other clinical and discovery programs," said Charles E. Bugg, Ph.D., Chairman and Chief Executive Officer of BioCryst. "BCX-1777 is in a Phase I/II clinical trial for patients with T-cell leukemias and lymphomas. Our discovery programs include tissue factor/factor VIIa, hepatitis C polymerase and complement component C1s. We will aim to continue to drive BCX-1777 through the clinic, and plan to file an Investigational New Drug application with the U.S. Food and Drug Administration on our tissue factor/factor VIIa lead candidate during the first quarter 2003. Additionally, we will continue to use our expertise in enzyme targets and structure-based drug design to advance our product development pipeline."
The Company will sponsor a conference call and webcast at 8:30 am EDT today, Tuesday, June 25, 2002, which is open to the public. Interested investors can listen to the call live over the Internet from the investor relations website at biocryst.com or videonewswire.com or by dialing +1-800-289-0496 and providing the passcode number 381421... |
