Abbott has reported positive results from the Phase 2 pilot study of its interferon-free combination regimen of ABT-450/r and ABT-072, intended for the treatment of hepatitis C (HCV).
ABT-450 is being developed by Abbott for use in combination with Abbott’s non-nucleoside polymerase inhibitors (ABT-333 and ABT-072) and NS5A inhibitor (ABT-267) to treat HCV.
The 12-week Phase 2 M12-267 study involved 11 treatment-naïve adults with host IL28B CC genotype from multiple ethnic backgrounds with non-cirrhotic HCV GT1 to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ABT-450/r 150/100mg QD and ABT-072 400mg QD plus ribavirin.
In the trial, the primary objective was percentage of patients with HCV RNA <25 IU/mL from week four through 12, while other trial endpoints included early virologic response, rapid virological response (RVR) and sustained viral response (SVR) through 24 weeks.
The study data showed that 91% of genotype 1 infected, treatment-naïve patients taking ABT-450/r and ABT-072 combined with ribavirin administered for 12 weeks, achieved SVR at 24 weeks (SVR24) and 82% of patients achieved SVR36.
Alamo Medical Research, US, medical director and lead investigator for the study Eric Lawitz said the sustained viral response rates in the study are encouraging as there are currently no treatment options for patients with HCV who cannot take or are intolerant to interferon.
"This is one of the earliest looks at mature data and it continues to demonstrate that a 12-week combination regimen of direct-acting antiviral treatments has the potential to offer high cure rates while eliminating the use of interferon," Lawitz added.
The drug-related adverse events were headache, fatigue, nausea and dry skin.
Abbott Infectious Disease Development divisional vice president Scott Brun said, "With a research portfolio that encompasses multiple direct-acting antiviral treatments in different drug classes, Abbott has the ability to quickly study a variety of combination regimens for HCV, with a focus on interferon-free regimens, to determine which has the greatest potential to help the largest number of patients."