DURHAM -- BioCryst Pharmaceuticals has suspended enrollment in a clinical trial for its most advanced drug candidate -- an intravenous treatment for flu. A company spokesman said it's likely the trial will be terminated.
The company announced Wednesday that an independent analysis of a Phase III trial testing the drug in patients admitted to the hospital with serious influenza found the difference was small between those taking the experimental drug, and those in the control group. The study was recommended to be terminated.
BioCryst was developing peramivir under a $234.8 million contract from the Biomedical Advanced Research Development Authority of the U.S. Department of Health and Human Services, according to a news release.
Robert Bennett, executive director of investor relations and communications at BioCryst, said company officials shared information with the department that the trial was "trending toward futility." He said the company officials will sift through the trial data before making a final decision about the trial.
"The most likely (outcome) is that the study would be terminated, but we'll go through the data analysis first, and then make that decision," Bennett said.
This was a second setback for the company recently. On Oct. 30, BioCryst announced the withdrawal of a new drug application for a potential Hepatitis C treatment, as a result of U.S. Food and Drug Administration concerns about the pre-clinical toxicity of the candidate at the drug levels needed to reduce the viral load in infected patients. However, the company said it planned to do additional pre-clinical studies.
"Both events represent setbacks, I think we have a plan for the Hepatitis C drug to do additional pre-clinical studies that could give us a more definitive view on its potential to...go back on a path toward entering human studies," Bennett said.
The company reported its third-quarter results on Thursday. BioCryst saw a net loss in the quarter of $9.7 million, which was down from a net loss of $14.5 million in the same period last year. Bennett said the company ended the quarter with about $44 million in cash, which, at the current utilization rate, is for more than a year's worth in cash.
Bennett also added that a condition of the proposed acquisition of Presidio is to complete an additional capital raise of a minimum of $60 million. He said that of that, $25 million is already committed by Presidio shareholders.
The company employs 42 workers Durham and 31 in Birmingham, Ala. ___
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