Abbott Announces Positive Data from Mid-Stage Trial of Hepatitis C Therapy...

Although it's still early in the clinical trial process, the news gets better and better with Direct Acting Antivirals as we head toward AASLD. This press release from Abbott focuses on Abbott's ABT-450 and one of two Abbott polymerase inhibitors, ABT-333 or ABT-072. Interim data points toward shortening therapy down to 12 weeks with ribavirin but sans interferon. Abbott doesn't specifically go into adverse events in this press release, which is a question everyone will likely be asking at the conference.

Abbott Announces Positive Data from Mid-Stage Trial of Hepatitis C Therapy

pharmpro.com

Oct 24 2011
Abbott on Friday announced interim data from mid-stage trials of its experimental hepatitis C drug combination that suggested patients could achieve a viral cure without use of interferon and that the duration of therapy could be about half as long as conventional therapies. Abbott’s Richard Gonzales, who will take over as CEO of the company's new presecription drug business following its split, commented that the therapy could "dramatically change the treatment landscape" for the disease, adding that "we’re on track to show patient cure rates in the 90 percent range."

In the trials, 44 previously untreated patients with hepatitis C were given ritonavir with Abbott's ABT-450 and one of two Abbott polymerase inhibitors, ABT-333 or ABT-072, and ribavirin for 12 weeks. All patients who remained in the studies achieved an early virologic response at 12 weeks, and of the 10 patients to date who were tested 24 weeks after completing the treatment course, nine had achieved a sustained virologic response, the company said. Abbott plans to present more detailed data on these and other trials of the drug regimen next year.


"While early, these results are unprecedented in that very high cure rates are being achieved ... with only 12 weeks of interferon-free therapy," Gonzalez commented. Abbott noted that the FDA has given fast track status to the regimen and indicated that it could reach the market by 2015. In addition, the drugmaker speculated that the treatment regimen could go on to capture $2 billion in annual sales.


Shares in Pharmasset, which is developing a similar therapy that includes two drugs versus Abbott’s four components, dipped 15 percent on the news. Investors had expected that Pharmasset’s treatment would not face competition from another therapy that doesn’t use interferon, commented Leerink Swann analyst Howard Liang. "We are seeing there is another way of achieving a regimen without interferon that looks like it will be competitive," he said, adding that "it will eventually all boil down to who has the better data."


However, Brean Murray Carret & Co. analyst Brian Skorney noted that "the two-drug combination has a better chance of a very clean safety profile. I continue to believe Pharmasset’s [therapy] will be better." Pharmasset will present new data on the therapy next month at the American Association for the Study of Liver Disease annual meeting.