|[November 07, 2012]
BioCryst Announces Outcome from the Peramivir Phase 3 Interim Analysis
RESEARCH TRIANGLE PARK, N.C. --(Business Wire)--
Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced completion of
the planned interim analysis of the peramivir Phase
3 trial in patients admitted to the hospital with serious influenza.
The difference between peramivir and control groups for the primary
endpoint was small and the recalculated sample size was greater than the
predefined futility boundary of 320 subjects. Based on this information,
the independent data monitoring committee (DMC) recommended that the
study be terminated for futility. No unexpected adverse events were
identified and the DMC expressed no concerns about the safety of
"The goal of this analysis was to reassess the sample size required for
the trial, and to make adjustments to the study if necessary. Based on
the DMC recommendation, we have suspended enrollment of patients in the
trial," said Dr.
William P. Sheridan, Senior Vice President & Chief Medical Officer
of BioCryst Pharmaceuticals. "We are proceeding with a full analysis of
unblinded data from the trial, and a final decision will be made
following completion of the analysis and further discussions with our
development partners; however, it is unlikely that peramivir development
for US registration will continue."
BioCryst has shared the DMC recommendation with the U.S. Department of
Health and Human Services Biomedical Advanced Research and Development
Authority (HHS/BARDA) and other development partners.
The interim analysis will be discussed by BioCryst management during the
Company's third quarter 2012 results conference call and webcast on
Thursday, November 8, 2012 at 8:30 a.m. Eastern Time.
Phase 3 Development of Peramivir
The peramivir Phase 3 U.S. registration trial ("301") is a multicenter,
randomized, double-blind, controlled study to evaluate the efficacy and
safety of 600 mg i.v. peramivir administered once-daily for five days in
addition to standard of care (SOC), compared to SOC alone, in adults and
adolescents who are hospitalized due to serious influenza. In February
2011, the primary efficacy analysis of the trial was amended to focus on
a subset of approximately 160 patients not treated with neuraminidase
inhibitors as SOC, in order to provide the greatest opportunity to
demonstrate a statistically significant peramivir treatment effect.
A total of 405 patients were enrolled in the overall trial population at
the time of the interim analysis data cutoff. The interimanalysis was
conducted on 119 patients enrolled in the primary efficacy population.
The interim analysis evaluated the difference in time to clinical
resolution between the peramivir group and the control group for the
subjects enrolled to date, and estimated the sample size for the primary
efficacy analysis population required to maintain adequate power and to
show statistical significance in the final study analysis.
Further details regarding the Phase 3 trial are available at: http://clinicaltrials.gov/ct2/show/NCT00958776.
The influenza virus causes an acute viral disease of the respiratory
tract. Unlike the common cold and some other respiratory infections,
seasonal flu can cause severe illness, resulting in life-threatening
complications. According to the CDC, an estimated 5% to 20% of the
American population suffers from influenza annually, and there are
approximately 3,000 to 49,000 flu-related deaths per year in the U.S.
Most at risk are young children, the elderly and people with seriously
compromised immune systems.
Peramivir is a potent, intravenously administered investigational
anti-viral agent that rapidly delivers high plasma concentrations to the
sites of infection. Discovered by BioCryst, peramivir inhibits the
interactions of influenza neuraminidase, an enzyme which is critical to
the spread of influenza within a host. In laboratory tests, peramivir
has shown activity against multiple influenza strains, including
pandemic H1N1 swine origin flu viral strains. Peramivir is being
developed under a $234.8 million contract from HHS/BARDA. In January
2010, Shionogi & Co., Ltd. launched intravenous (i.v.) peramivir in
Japan under the name RAPIACTA® to treat patients with influenza and in
August 2010, Green Cross Corporation announced that it had received
marketing and manufacturing authorization for i.v. peramivir in Korea to
treat patients with influenza A & B viruses, including H1N1 and avian
influenza. For more information about peramivir please visit BioCryst's
Web site at http://www.biocryst.com/peramivir.
BioCryst Pharmaceuticals designs, optimizes and develops novel small
molecule drugs that block key enzymes involved in infectious and
inflammatory diseases. BioCryst currently has two late-stage development
programs: peramivir, a viral neuraminidase inhibitor for the treatment
of influenza, and ulodesine (BCX4208), a purine nucleoside phosphorylase
(PNP) inhibitor for the treatment of gout. In addition, BioCryst is
developing two preclinical compounds: BCX5191, a nucleoside analog
inhibitor of HCV RNA polymerase (NS5B) for hepatitis C, and BCX4161, an
oral inhibitor of plasma kallikrein for hereditary angioedema. Utilizing
state-of-the-art structure-guided drug design and crystallography,
BioCryst continues to discover innovative compounds with the goal of
addressing unmet medical needs of patients and physicians. For more
information, please visit the Company's website at www.BioCryst.com.
This press release contains forward-looking statements, including
statements regarding future results, performance or achievements. These
statements involve known and unknown risks, uncertainties and other
factors which may cause BioCryst's actual results, performance or
achievements to be materially different from any future results,
performances or achievements expressed or implied by the forward-looking
statements. 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 HHS/BARDA may further condition, reduce or eliminate future funding
of the peramivir program; that BioCryst or its licensees may not be able
to enroll the required number of subjects in planned clinical trials of
its product candidates and that such clinical trials may not be
successfully completed; that the company or its licensees may not
commence as expected additional human clinical trials with product
candidates; that the FDA may require additional studies beyond the
studies planned for product candidates or may not provide regulatory
clearances which may result in delay of planned clinical trials,
clinical hold with respect to such product candidate or the lack of
market approval for such product candidate; that ongoing and future
preclinical and clinical development may not have positive results; that
the company or its licensees may not be able to continue future
development of current and future development programs; that such
development programs may never result in future product, license or
royalty payments being received; that the companies may not be able to
retain its current pharmaceutical and biotechnology partners for further
development of its product candidates or may not reach favorable
agreements with potential pharmaceutical and biotechnology partners for
further development of product candidates; that its actual cash burn
rate may not be consistent with its expectations; that 2012 operating
expenses and cash usage will be within management's expected ranges.
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, Quarterly Reports on Form 10-Q, and current
reports on Form 8-K, all of which identify important factors that could
cause the actual results to differ materially from those contained in
BioCryst's projections and forward-looking statements.
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