Achillion Pharmaceuticals Inc. announced the company has begun dosing ACH-3422, a uridine-analog nucleotide polymerase inhibitor, for seven days in patients with genotype 1 chronic hepatitis C viral infection (HCV) in its ongoing Phase 1 clinical trial. Proof-of-concept results from this trial are expected to be reported during the fall of 2014. Furthermore, Achillion announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on sovaprevir, an NS3/4A protease inhibitor, to permit the conduct of trials in patients with HCV. Sovaprevir doses of 200 mg once daily, the previously evaluated dose that was well-tolerated with clinical activity in two completed Phase 2 studies, may be used in additional therapeutic clinical trials.

 

“We believe Achillion is uniquely positioned with clinical candidates in each of the nucleotide, NS5A and protease inhibitor categories needed to advance both dual and triple commercially competitive combination therapies that can treat the spectrum of patients with HCV. We remain focused on developing regimens utilizing ACH-3422 and ACH-3102, our second-generation Phase 2 NS5A inhibitor, and the second half of 2014 will feature multiple milestones in that program,” commented Milind Deshpande, president and CEO. “Our HCV pipeline also provides the opportunity to add a NS3/4A protease inhibitor, such as sovaprevir or ACH-2684, in order to explore triple-direct acting antiviral regimens that can potentially shorten treatment durations to less than eight weeks. We will determine how best to integrate our protease inhibitors into our combination development programs as data from our on-going trials emerge.”

 

“With the start of patient dosing with ACH-3422, our Phase 1 uridine-analog nucleotide, we remain on track to report proof-of-concept results in the fall, and plan on initiating all oral combination studies with ACH-3422 by the end of 2014. We are also very pleased that the effort by the Achillion team, working in collaboration with the FDA, has resulted in this response for the sovaprevir program,” commented David Apelian, executive vice president and chief medical officer.

 

Sovaprevir is a Phase 2 NS3/4A protease inhibitor being developed for the potential treatment of chronic HCV infection. To date, approximately 550 subjects have been exposed to sovaprevir with clinical activity reported in two Phase 2 12-week treatment duration studies, one in combination with pegylated-interferon/ribavirin and one in combination with ACH-3102 in which the combination achieved 100% SVR12 in patients with genotype 1b HCV. The FDA removed the clinical hold to permit the conduct of therapeutic trials with a maximum of 200 mg once daily of sovaprevir in HCV patients and in single dose trials in healthy volunteers, but maintained a partial clinical hold for multiple dose studies that may be conducted in healthy volunteers, requiring prior review and approval of the protocol by the FDA. Achillion expects to continue to work collaboratively with the FDA on the continued clinical development of sovaprevir.

 

Date: June 10, 2014

Source: Achillion Pharmaceuticals