Today, Achillion Pharmaceuticals, Inc. announced new trial results, which demonstrated that its experimental hepatitis C drug, when used in combination with Gilead Sciences Inc’s Sovaldi, eliminated the virus after just six weeks of therapy.
The company provided an update on interim results from the ongoing interferon-free, ribavirin-free, Phase II study, evaluating the efficacy, safety, and tolerability of six weeks of 50 mg of ACH-3102 and 400 mg of sofusbuvir, a marketed nucleotide polymerase inhibitor, in treatment-naïve genotype 1 hepatitis C virus (HCV) infected patients. In the mid-stage study, 100 percent of patients in the six-week treatment duration arm achieved sustained viral response 12 weeks (SVR12) after completion of therapy, which included patients with high baseline viral load.
If the combination of Sovaldi and Achillion’s ACH-3102 continue to show this level of effectiveness, the treatment could potentially rival Gilead’s Harvoni and AbbVie’s Viekira Pak, which achieves this response after 8 weeks and 12 weeks of therapy, respectively. Achillion’s announcement sent the company’s shares up 12 percent.
“The ability to further shorten treatment duration to only six weeks and maintain excellent SVR12 rates remains the goal for clinicians and patients, and I am pleased that these Phase 2 results support that goal. The profile of ACH-3102, represents an important and exciting treatment option to shorten treatment duration for patients infected with HCV,” said Professor Edward Gane, MD, Deputy Director and Hepatologist, New Zealand Liver Transplant Unit, Auckland City Hospital in New Zealand, and Lead Investigator in the Phase 2 study of ACH-3102 and sofosbuvir and the ACH-3422 nucleotide inhibitor program.
Achillion’s CEO Milind Deshpande said that these results represent the shortest duration and highest response achieved to date with any two-drug, direct-acting antiviral regimen for hepatitis C, and now plans to evaluate four- and six-week treatment durations.
“The achievement of 100% SVR12 after six weeks of treatment with a dual NS5A-nucletoide regimen, even in patients with high baseline viral load who would otherwise require extended duration treatments, supports our belief that ACH-3102 can unleash the potential of this combination to drive down treatment duration,” commented Dr. David Apelian, Executive Vice President of Clinical Development and Chief Medical Officer at Achillion. “We are currently preparing to initiate our SPARTA Phase 2 program which evaluates short term treatment durations with our proprietary once-daily regimens of ACH-3102 and ACH-3422, with or without sovaprevir, for treatment naïve genotype 1 HCV patients. In parallel, we plan on exploring sofosbuvir-sparing regimens that will leverage shorter durations of sofosbuvir in combination with ACH-3102 and sovaprevir as part of our global development program.”
Source: Achillion Pharmaceuticals, Inc.