peramivir failed in a clinical trial, page-8

More data on Peramivir study

http://sev.prnewswire.com/health-care-hospitals/20090508/NY1367708052009-1.html

Interesting parts

BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) today announced that, based on discussions with the U.S. Department of Health and Human Services/Biomedical Advanced Research and Development Authority (HHS-BARDA), it is preparing a portion of its inventory of finished peramivir for addition to the U.S. Centers for Disease Control and Prevention (CDC) Strategic National Stockpile. This inventory is sufficient for the treatment of approximately one thousand patients and will be delivered in the event that the government so instructs. Intravenous (i.v.) peramivir is currently undergoing a pre-emergency use authorization (EUA) review. Government agencies are considering the future option of providing peramivir through an EUA in the event of a severe influenza outbreak with significant hospitalizations.


"BioCryst is working diligently with government agencies to provide i.v. peramivir as a treatment option for an influenza emergency," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst. "With its parenteral route of administration, peramivir has the potential to help patients who may have difficulty with an oral or inhaled anti-viral medication.


Intramuscular Peramivir Phase 2 Study Results for Seasonal Influenza

BioCryst also announced preliminary results from its Phase 2 study of intramuscular (i.m.) peramivir for the treatment of seasonal influenza. While the study demonstrated a numerical trend in its primary endpoint of improvement in the median time to alleviation of symptoms (TTAS) in subjects with confirmed, acute, uncomplicated influenza infection versus placebo, the difference between the two study groups was not statistically significant.


The median TTAS was 91.1 hours for those receiving a single 600 mg injection of i.m. peramivir, compared to 106.1 hours observed in those patients receiving placebo (p=0.22). The trial indicated that peramivir was generally safe and well tolerated with a similar adverse event profile noted in the peramivir and placebo treatment groups.


Recent Clinical Highlights

Peramivir Program

BioCryst's partner, Shionogi & Company, Ltd. (Shionogi), initiated a Phase 3 program with i.v. peramivir in the outpatient setting. The Phase 3 study is a 1,050 subject study. BioCryst anticipates that Shionogi will complete its study within this influenza season and expects to file for new drug approval in Japan by fiscal year end. Shionogi initiated its Phase 3 study based on positive clinical results from a Phase 2 study that investigated the efficacy and safety of a single administration of 300 mg and 600 mg. i.v. peramivir for the treatment of seasonal influenza in the outpatient setting. The Phase 2 study, which was also sponsored by Shionogi, met its primary endpoint of time to alleviation of symptoms for both the 300 mg dose (p=0.0046) and 600 mg dose (p=0.0046).