8/15/2014 7:12:05 AM
Gilead Shaky As Achillion Pharmaceuticals' Hepatitis C Drug Cures All Patients In Mid-Stage Trial
August 15, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Today, Connecticut-based drug company Achillion Pharmaceuticals, Inc. (ACHN) released the results of its eight-week phase 2 trial study examining a ribavirin-free regimen of ACH-3102 and sofosbuvir for genotype 1 HCV. After testing the drug in 12 patients with the hepatitis C virus, researchers found that 100 percent of them remained free of the virus four weeks after treatment.
Now, Achillion is looking to administer the drug in 12 more patients, one dose a day, over the course of six weeks.
This news comes as Gilead (GILD) and AbbVie (ABBV) both look to receive FDA approval for hepatitis C combination therapies of their own by the end of this year. Achillion has now made a significant case for itself as a competitor in this realm.
"ACH-3102 continues to demonstrate good safety and tolerability through three Phase 2 studies,” said David Apelian, M.D., Ph.D., Executive Vice President and Chief Medical Officer at Achillion. “We believe these studies also confirm a differentiated efficacy profile for an NS5A inhibitor. Achieving 100 percent SVR4 with eight weeks of treatment with sofosbuvir serving as a nucleotide proxy indicate that dosing 50 mg once daily of ACH-3102 plus a nucleotide inhibitor has the potential to achieve commercially competitive results for curing HCV in a short duration, ribavirin-free doublet.”
In addition to the drug treatment showing positive signs after four weeks, researchers were not able to see any negative side effects as a result of the therapy.
"As we continue to achieve clinical milestones, we remain focused on execution of the broader clinical development strategy for our HCV portfolio,” said Milind Deshpande, Ph.D., President and Chief Executive Officer of Achillion. “We expect that Phase 1 proof-of-concept results with ACH-3422 will be reported during the fall of this year, which we anticipate will lead to the start of a Phase 2 combination program to evaluate our proprietary doublet regimen for an eight week, or potentially shorter, treatment regimen for HCV that will begin before the end of 2014."
More than 150 million people around the world are estimated to have hepatitis C, which causes inflammation of the liver. Approximately 5 million of these people live in the U.S. Nearly three-fourths of the people living with the disease are undiagnosed, and going without treatment for an extended period of time can lead to permanent liver damage.
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