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Gilead preps late-stage sprint on blockbuster hep C studies

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It looks as if Gilead can't be shamed into a late-stage hepatitis C collaboration with Bristol-Myers Squibb after all.

Despite taking heat for its refusal to commit to BMS ($BMY), Gilead ($GILD) has now mapped out a plan to get its own in-house combo into a late-stage study later this year. And it believes it has the goods to jump ahead, nailing down the pivotal data needed for a 2014 regulatory filing after a high-speed, forced march into the clinic.

A few weeks ago BMS CEO Lamberto Andreotti blasted Gilead for refusing to push ahead on a Phase III study combining Gilead's GS-7977--purchased for a princely sum when the company bought out Pharmasset for $11 billion--with BMS's daclatasvir after the oral treatment offered stellar results in a mid-stage study. Daclatasvir is an NS5a inhibitor and the combo produced high cure rates at 12 weeks for the genotype 2/3 as well as genotype 1 hep C groups. Not surprisingly, BMS--which acquired the nuc INX-189 in the $2.5 billion Inhibitex buyout-- wanted to jump into a late-stage study with a combo that promised to swiftly move ahead as a new market leader. And experts in the field were left chomping at the bit.

Dr. Scott Friedman, chief of liver diseases at the Mount Sinai School of Medicine, chided Gilead, telling Bloomberg last April that the main focus should be on patients, not stockholders.

Gilead, though, struggled to remain free, with R&D chief Norbert Bischofberger saying there was no need to jump "wildly" ahead. And in his presentation to investors last week, Bischofberger mapped out a two-year clinical game plan that matches GS-5885--its own NS5a inhibitor--with 7977. A Phase I, fixed-dose combination study was launched just days ago, he said in the quarterly call.  And if investigators get the right read on bioavailability, they plan to start the Phase III in a matter of months.

"This Phase III study is planned as a forearm randomized trial in 800 patients, evaluating the fixed dose combination with or without Ribavirin for either 12 or 24 weeks in treatment-naïve genotype 1 infected patients," said Bischofberger. "The study will contain an interim futility analysis after the first 200 patients or 50 per arm have been enrolled, an independent data, safety monitoring board will evaluate the SVR4 rates of the 12-week treatment arms. If the predefined response rates are met, then the remaining 600 patients will be subsequently enrolled." 

Success in the first late-stage study would pave the way to a second confirmatory study, launched next year. Regulatory filings could be filed in 2014. And that could pave the way to a monumental blockbuster approval, as the hepatitis C patient population now waits for a new treatment that won't require interferon injections.

Four late-stage studies of 7977 with Ribavirin are underway now and Bischofberger says regulatory filings for that could come as early as the middle of next year.

- here's the story from Bloomberg on the combo study

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