Abbott Releases Phase 2 Results - Drug Discovery and Development

Abbott and Enanta Pharmaceuticals announced data from Co-Pilot, an interferon-free, Phase 2 study of Abbott’s direct-acting antiviral medicines for the treatment of hepatitis C (HCV) that found that more than 90% of patients new to HCV treatment achieved sustained viral response through 12 weeks (SVR12). Results were released at a press conference at the International Liver Congress 2012 (ILC 2012), the annual meeting of the European Association for the Study of the Liver (EASL), in Barcelona, Spain, and will also be presented in an oral platform presentation at the latebreaking trials session on Saturday, April 21.

In the three-arm study different doses of ABT-450/r, plus ABT-333 and ribavirin administered for 12 weeks showed sustained virological response at 12-weeks post treatment (SVR12) in 95% and 93% of treatment-naive genotype 1 (GT1) patients, with no post-treatment relapses. In these patients, response was independent of HCV subtype, host IL28B genotype or dose of ABT-450/r.

In addition, SVR12 was achieved in 47% of patients who were previous non-responders to past HCV treatment.

“As we get our first look at longer term response data for interferon-free regimens for the treatment of HCV, we remain extremely encouraged by the levels of sustained response we are seeing in patients new to treatment and in patients who had failed prior treatment,” said Fred Poordad, M.D., chief of hepatology at Cedars-Sinai Medical Center in Los Angeles, and the lead investigator for Co-Pilot. “We are seeing this level of sustained response with only 12 weeks of therapy, supporting the goal of introducing an interferon-free, all-oral regimen of direct-acting antiviral medications as an important new treatment option for HCV.”

Current treatments for HCV remain interferon-based. A significant number of HCV patients are unable or unwilling to take interferon due to contraindications and/or some of the most commonly reported side effects, which may include flu-like symptoms, depression, and insomnia. Specifically targeted antiviral therapies for HCV, such as protease inhibitors and non-nucleoside polymerase inhibitors, may have the potential to increase the proportion of patients in whom the virus can be eradicated.

Date: April 19, 2012
Source: Abbott