Bristol-Myers Hepatitis C Combo Therapy Shows Promise

Bristol-Myers Hepatitis C Combo Therapy Shows Promise in Study
Bristol-Myers Squibb plans to take the therapy into final-stage trials in 2014. Photographer: Daniel Acker/Bloomberg

Bristol-Myers Squibb Co., which took a $1.8 billion charge in the third quarter after ending work on a drug for hepatitis C, may have hope for a new regimen shown to clear the liver infection from patients in a study.

Results from a 16-patient trial presented today at the American Association for the Study of Liver Diseases in Boston showed that combining three of the company’s experimental medicines, daclatasvir, asunaprevir and BMS-791325, cleared the hepatitis C virus in 94 percent of patients. Bristol-Myers plans to take the therapy into final-stage trials in 2014.

Bristol-Myers is among several drugmakers including Abbott Laboratories and Gilead Sciences Inc. that are competing to be the first to market with a treatment for the liver disease that doesn’t rely on yearlong, weekly injections of the drug interferon. The new, experimental drugs inhibit the hepatitis C virus’s ability to replicate, as opposed to existing therapies that boost the body’s immune system to fight the disease.

Brian Daniels, Bristol-Myers’s senior vice president of global development and medical affairs, called the results encouraging. “We look forward to studying it further,” he said in a statement.

Bristol-Myers’ trial studied 16 patients who hadn’t been treated before. Fifteen were found to have cleared the virus from their blood 12 weeks after stopping therapy, and the 16th patient didn’t stay in the trial long enough for investigators to count the data as a success, the company said.

In Competition

The positive results comes after New York-based Bristol-Myers announced in August that it was ending development of the drug it got with its February purchase of Inhibitex Inc., after patients on the pill developed heart failure. Success for the new combination therapy would put the company back in competition with Gilead and Abbott for a slice of what could be a $20 billion market by 2020.

Yesterday, Bristol-Myers also announced results from a trial of 18 patients who got 12 weeks of daclatasvir and asunaprevir. Of those, 78 percent had no detectible levels of the virus 12 weeks after ending the drugs. The patients had previously received interferon treatments for their disease and hadn’t been cured. Bristol-Myers is trying to get the combination approved in Japan, where a subset of patients who respond best to the combination are most common, according to the company.

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