December 22, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Investors who have been closely watching the development of an adjunct hepatitis C to be given along with Sciences’ blockbuster drug Solvadi were thrilled Monday when the drug’s maker, Achillion Pharmaceuticals , said the therapy had passed two clinical trials with flying colors.
Achillion said the drug, ACH-3102, an adjunctive therapy for Sovaldi, had shown potential for a “Best-In-Disease” HCV Regimen after it showed a 100 percent SVR4 following a dual 6-week ACH-3102-based regimen and a separate 4.8 Log10 reduction with combo drug ACH-3422.
ACH-3102 is a second-generation NS5A inhibitor that has received Fast Track designation from the U.S. Food and Drug Administration.
“We believe that achievement of 100 percent SVR4 in six weeks in the ACH-3102 proxy study, combined with the high potency and safety demonstrated by ACH-3422, highlights the ability of our exceptional, fully owned portfolio to excel in the HCV market,” said Milind Deshpande, president and chief executive officer of Achillion.
“We look forward to initiating in 2015 short duration, pan-genotypic Phase 2 therapeutic trials to evaluate the doublet of ACH-3102 and ACH-3422, with the ultimate goal of improving patient care and access to treatment.”
A six-week dual NS5A–Nuc regimen of ACH-3102 and sofosbuvir was “safe and well-tolerated” with 100 percent SVR4 for treatment-naïve genotype 1 HCV, said Achillion, while the ACH-3422 proof-of-concept trial showed it was safe and well-tolerated at doses of 50 mg–700 mg once daily achieving 4.8 log10 reduction with 700 mg dose after 14 days.
Market watchers have been keeping a close eye on Achillion recently as it waits for FDA approval for the drug, which if allowed to be used with, could ride that blockbuster’s billion dollar coattails.
Sovaldi, also known as sofosbuvir, is a once-daily oral tablet that was approved by the FDA for the treatment of chronic hepatitis C in December 2013. It and its sister drug Harvoni, also made by Gilead Sciences , have shown success and cure rates in the 90th percentile, exciting both clinicians and Wall Street alike.
“It is our hope that Sovaldi will mark the beginning of a new era in hepatitis C treatment. Gilead is proud to have played a role in bringing about this important therapeutic advance and we would like to extend our thanks to the many patients and physicians who partnered with us on Sovaldi’s clinical studies,” John Martin, chairman and chief executive officer of Gilead Sciences, said at the time of the approval.
The hepatitis C virus is the most common cause of viral hepatitis, an inflammation of the liver. Approximately 150 million people are thought to be living with the virus around the world, and 5 million of them live in the U.S. Approximately three-fourths of the population living with HCV is undiagnosed, and allowing the disease to go untreated can result in liver cancer, liver failure or death.
