Biotechnology company BioCryst Pharmaceuticals, Inc. (BCRX) announced Wednesday favorable preclinical results for the preclinical compound BCX5191 for treatment of hepatitis C. The company's shares reacted sharply, and is up 25 percent in pre-market trading.
The preclinical results revealed that BCX5191 demonstrated high oral bioavailability, and the drug is actively transported into the liver. A single oral dose in rats saw liver BCX5191 triphosphate levels exceed the IC50 values for genotypes 1-4 through 24 hours.
The compound is a novel adenine nucleoside analog targeting viral RNA polymerase for the potential treatment of hepatitis C.
The company noted that BCX5191 showed no inhibition of human RNA polymerase and no evidence of toxicity from standard in vitro screens. The company added that BCX5191 has the potential to be the backbone of best-in-class oral treatment regimens for hepatitis C patients.
BioCryst said it successfully completed in vitro and in vivo studies in which BCX5191 exhibited potent and selective pan-genotypic antiviral activity against the hepatitis C polymerase enzyme.
"BCX5191 has met stringent preclinical criteria to advance to IND-enabling studies. We expect this program to be ready to file for first-in-human studies during the fourth quarter of 2012," said Dr. William Sheridan, Senior Vice President & Chief Medical Officer of BioCryst Pharmaceuticals.
The company expects to file an Investigational New Drug or IND, application with the U.S. FDA for BCX5191 during the second half of 2012, and plans for first-in-human studies during the fourth quarter 2012.
BioCryst's drug pipeline also includes Peramivir, a neuraminidase inhibitor for the treatment of influenza, and Forodesine, an orally-available purine nucleoside phosphorylase inhibitor for hematological malignancies.
BCRX closed Tuesday's regular trading session at $3.67, down $0.21 on a volume of 0.36 million shares.
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