Bristol-Myers Squibb Co. (BMY:US), the New York drugmaker that gained 22 percent the past year, said its combination of three experimental medicines for hepatitis C successfully cleared the virus in 15 of 16 patients.
The results of the 24-week trial were released today before the start of the European Association for the Study of the Liver’s annual meeting in Amsterdam. The company plans to pick a dose for the treatment and move it into final-stage trials later this year.
Bristol-Myers’s pill combination doesn’t rely on yearlong, weekly injections of interferon, nor does it use ribavirin, which can damage the liver and cause anemia. The new drugs stop the virus from copying itself, rather than boosting the body’s defenses to fight off the liver disease. Drugmakers are seeking pills that are easier to use and reduce side effects for the estimated 150 million patients worldwide with hepatitis C.
“The great news with these oral combos is that it takes less time to explain to patients how to take their medicine,” said Doug Manion, the New York-based drugmaker’s head of neuroscience and virology research. It spares patients self- injection and the duration of treatment is shorter, he said.
Bristol-Myers is competing with AbbVie Inc. (ABBV:US), Merck & Co. (MRK:US), Gilead Sciences Inc. (GILD:US) and Vertex Pharmaceuticals Inc. (VRTX:US) among others to develop new pills to eliminate the current therapy, which calls for interferon and ribavirin. That standard treatment can cause flu-like side-effects for as long as 48 weeks. The market for the new therapies is estimated at $20 billion by 2020.
The company last year took a $1.8 billion charge and stopped development of an experimental hepatitis C drug gained in its February 2012 purchase of Inhibitex Inc. after patients on the pill developed heart failure.
The three drugs in Bristol-Myers’s combination medicine are daclatasvir, asunaprevir, and BMS-791325. Interim data from the clinical trial was previously presented at the American Association for the Study of Liver Diseases in Boston.
The clinical trial studied patients who hadn’t been treated before. The groups were given therapy combinations with different doses of BMS-791325.
Of those given the combination with the 75-milligram dose for 12 weeks, the virus was undetectable in 15 of the 16 patients when measured 24 weeks after stopping therapy. The 16th patient didn’t stay in the trial long enough for investigators to count the data as a success, the company said.
In a second group treated for 24 weeks at the same dose, 14 of 16 patients also cleared the virus from their blood 24 weeks after stopping the therapy. Two patients left the trial.
Bristol-Myers also presented interim data in an arm of the trial using a 150-milligram dose of BMS-79135. In one subgroup, 18 patients were on the drug for 12 weeks. The virus was undetectable 12 weeks after the treatment ended in 16 of the 18. The data on their viral response at 24 and 36 weeks wasn’t available.
In another study group, patients were given the drug for 24 weeks. Four weeks after stopping the therapy, 15 of 16 had cleared the virus. Data on the patients’ response 12 weeks after treatment wasn’t yet available.
It’s not clear why the results from the 150 milligram dose were different, Manion said.
The most common side-effect was a headache. Two serious adverse events were reported, one of which was determined to be unrelated to the study drug. The other was blood vessel constriction in the brain.
Another study with the same design will be run to verify the safety findings, Manion said.
The U.S. Centers for Disease Control and Prevention has recommended all baby boomers, defined by the agency as those born from 1945 to 1965, get tested for the liver infection. Testing may prevent cirrhosis and liver cancer, both of which result from hepatitis C infection, the health officials said.
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