FDAnews Drug Daily Bulletin

AbbVie’s Initial Phase III Results Show Promise for Hep C Candidate

Nov. 19, 2013

AbbVie on Monday released the first of six SAPPHIRE Phase III trial results for its hepatitis C candidate, M11-646. The rosy results set the drugmaker up for regulatory filings in early 2014.

M11-646 is an investigational three direct-acting-antiviral (3D) regimen plus ribavirin in patients chronically infected with genotype 1 (GT1) hepatitis C virus (HCV).  The SAPPHIRE-I study showed that patients new to therapy receiving the all-oral, interferon-free therapy achieved high rates of virologic response, Scott Brun, vice president, pharmaceutical development, at AbbVie said.

The study consisted of 631 GT1 treatment-naive patients with no evidence of liver cirrhosis — randomizing 473 patients to the 3D regimen plus ribavirin for 12 weeks, and 158 to placebo. Following the first 12 weeks, placebo patients then received open-label treatment with the 3D regimen plus ribavirin for 12 weeks.

SAPPHIRE-I is part of a larger drug development program involving more than 2,300 GT1 patients in more than 25 countries.

M11-646’s 3D regimen consists of a boosted protease inhibitor, an NSSA inhibitor and a non-nucleoside polymerase inhibitor. The regimen with and without ribavirin for HCV GT1 was designated as a breakthrough therapy by the FDA in May. — Nick Otto

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