BIOCRYST PHARMACEUTICALS, INC. ANNOUNCES PRELIMINARY PHASE III TRIAL RESULTS FOR INFLUENZA NEURAMINIDASE INHIBITOR, PERAMIVIR
BIOCRYST PHARMACEUTICALS, INC. ANNOUNCES PRELIMINARY PHASE III TRIAL RESULTS FOR INFLUENZA NEURAMINIDASE INHIBITOR, PERAMIVIR
June 25, 2002
Birmingham, Alabama - June 25, 2002 - BioCryst Pharmaceuticals, Inc. (Nasdaq NM: BCRX) 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 www.biocryst.com or http://www.videonewswire.com/event.asp?id=6122 or by dialing 1-800-289-0496 and providing the passcode number 381421.
For those unable to listen at the designated time, the webcast will remain available for replay over BioCryst's investor relations website until July 17, 2002. A conference call replay will also be available from approximately 12:30 p.m. EDT on Tuesday, June 25, 2002 through midnight Thursday, June 27, 2002 by dialing 1-888-203-1112 and entering passcode 381421.
Company Background
BioCryst Pharmaceuticals, Inc. designs, optimizes and develops novel drugs that block key enzymes essential for viral, cardiovascular and oncologic disease processes. BioCryst integrates the necessary disciplines of biology, crystallography, medicinal chemistry and computer modeling to effectively use structure-based drug design to discover and develop small molecule pharmaceuticals. Enrollment in a Phase I/II trial for one of BioCryst's product candidates, BCX-1777, is underway at M.D. Anderson Cancer Center for patients with T-cell leukemias and T-cell lymphomas. BioCryst has several new enzyme targets in drug discovery including tissue factor/factor VIIa, hepatitis C polymerase and complement component C1s. For more information about BioCryst, please visit the company's web site at www.biocryst.com.
These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, BioCryst's current and future development of BCX-1777, progress with respect to continuing Phase I/II development and clinical trials of BCX-1777, whether BioCryst will be able to drive BCX-1777 through the clinic, whether BioCryst can file an Investigational New Drug application (IND) for tissue factor/factor VIIa during the first quarter of 2003 or at all, and whether BioCryst will have sufficient financial and other resources to continue its product development on tissue factor/factor VIIa, hepatitis C polymerase and complement component C1s. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include that we may not be able to enroll the required number of subjects, or any at all, in clinical trials of BCX-1777, that we may not be able to continue future development of BCX-1777 or any of our other current development programs including tissue factor/factor VIIa, hepatitis C polymerase and complement component C1s, that BCX-1777 or our other development programs may never result in future license or royalty payments being received by BioCryst, that BCX-1777 or any of our other product candidates may not receive required regulatory clearances from the FDA or that BioCryst may not be able to expand its product development pipeline. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, which identify important factors that could cause the actual results to differ materially from those contained in the projections or forward-looking statements.
Contacts:
BioCryst Pharmaceuticals, Inc.
A.K. Schleusner (205) 444-4600
Noonan Russo/Presence Euro RSCG
Mary Claire Duch (212) 845-4278