BioCryst Announces Outcome from the Peramivir Phase 3 Interim Analysis
BioCryst management to discuss outcome during its third quarter
2012 results call now scheduled
"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.
BioCryst has shared the DMC recommendation with the
The interim analysis will be discussed by BioCryst management during the
Company's third quarter 2012 results conference call and webcast on
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
A total of 405 patients were enrolled in the overall trial population at the time of the interim analysis data cutoff. The interim analysis 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.
About Influenza
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.
About Peramivir
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
About BioCryst
Forward-Looking Statements
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
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or
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Catherine Kyroulis, 212-301-7174
(Media)
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