Drug Discovery & Development - November 01, 2010
Abbott and Enanta Pharmaceuticals announced positive results from a Phase 2 study of ABT-450/r, an investigational, oral protease inhibitor being developed for the treatment of hepatitis C (HCV) infection. Initial 3-day and 4-week results suggest that ABT-450/r (ABT-450 with 100mg of ritonavir to support once-daily dosing) demonstrates potent antiviral activity in treatment-naïve adults. Results show that more than 90 percent of patients (21 of 23) on study drug achieved HCV-RNA levels <25 IU/mL at four weeks. Results were presented today at the American Association for the Study of Liver Disease annual meeting in Boston.
Key findings:
• After three days, treatment with ABT-450/r alone resulted in statistically significant, 4-log mean reductions of HCV RNA, across the three dose ranges of ABT-450 (50mg, 100mg, 200mg, once-daily dosing) compared to placebo
• At week four, 91.3 percent (21 of 23) of patients receiving ABT-450/r in combination with standard of care (SOC) – pegylated alpha interferon and ribavirin (pegIFN/RBV) – achieved HCV-RNA <25 IU/ml
• Safety appears consistent to that expected with SOC
"In spite of the progress that has been made in HCV treatment, limitations in efficacy remain with the current standard of care," Fred Poordad, M.D., chief of hepatology at the Liver Disease and Transplant Center at Cedars-Sinai Medical Center in Los Angeles, and one of the investigators for the study. "The initial results of
ABT-450/r in patients with HCV suggest that ABT-450/r has favorable potency in the most common HCV genotype and that ABT-450/r could be an important element in a combination direct-acting antiviral regimen for treatment of HCV."
Date: November 1, 2010
Source: Abbott
Key findings:
• After three days, treatment with ABT-450/r alone resulted in statistically significant, 4-log mean reductions of HCV RNA, across the three dose ranges of ABT-450 (50mg, 100mg, 200mg, once-daily dosing) compared to placebo
• At week four, 91.3 percent (21 of 23) of patients receiving ABT-450/r in combination with standard of care (SOC) – pegylated alpha interferon and ribavirin (pegIFN/RBV) – achieved HCV-RNA <25 IU/ml
• Safety appears consistent to that expected with SOC
"In spite of the progress that has been made in HCV treatment, limitations in efficacy remain with the current standard of care," Fred Poordad, M.D., chief of hepatology at the Liver Disease and Transplant Center at Cedars-Sinai Medical Center in Los Angeles, and one of the investigators for the study. "The initial results of
ABT-450/r in patients with HCV suggest that ABT-450/r has favorable potency in the most common HCV genotype and that ABT-450/r could be an important element in a combination direct-acting antiviral regimen for treatment of HCV."
Date: November 1, 2010
Source: Abbott
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