Achillion Achieves 100% SVR12 In Phase II Trial

Achillion Pharmaceuticals, Inc. recently announced updated interim results from the ongoing interferon-free, ribavirin-free, Phase II study to evaluate the efficacy, safety, and tolerability of 6 weeks of 50 mg of ACH-3102 and 400 mg of sofosbuvir, a marketed nucleotide polymerase inhibitor, in treatment-naïve genotype 1 HCV-infected patients. The primary objective of the study is determination of sustained viral response 12 weeks (SVR12) after completion of therapy. One hundred percent of patients (12/12) in the 6-week treatment duration arm achieved SVR12, which included patients with high baseline viral load.

“The ability to further shorten treatment duration to only 6 weeks and maintain excellent SVR12 rates remains the goal for clinicians and patients, and I am pleased that these Phase II 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,” commented 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 II study of ACH-3102 and sofosbuvir and the ACH-3422 nucleotide inhibitor program.

“Our goal is to deliver short duration, widely accessible treatments to all HCV patients,” said Dr. Milind Deshpande, President and Chief Executive Officer of Achillion. “We believe that these results with ACH-3102 represent the shortest duration and highest response achieved to date with any two-drug, direct-acting antiviral regimen for HCV. Given the exceptional profile of ACH-3102, we will now be evaluating 4- and 6-week treatment durations that leverage all of our HCV assets, including ACH-3102, ACH-3422, and sovaprevir.”

This ongoing study is a Phase II open-label, randomized, partial-crossover study to evaluate the efficacy, safety, and tolerability of 8 and 6 weeks of 50 mg of ACH-3102 and 400 mg of sofosbuvir, a marketed nucleotide polymerase inhibitor, once daily, in treatment-naïve genotype 1 HCV-infected patients. Initially, 18 patients were enrolled, including 6 observational patients, into an 8-week treatment cohort.

Following the achievement of 100% SVR12 (12/12) in the 8-week cohort, the 6-week treatment cohort was initiated. In all, 18 patients were enrolled, including 12 active and 6 observational patients. Mean baseline HCV RNA viral load was 10 million (7 log10) IU/ml, range 2 million (6.23 log10) – 97 million (7.99 log10) IU/ml, including 7 patients with baseline HCV RNA viral load exceeding 6 million (6.78 log10) IU/ml. Of the 12 active patients enrolled, 7 patients were genotype 1a, and 5 were genotype 1b.
Twelve weeks after the completion of therapy, 100% (12/12) achieved SVR12, independent of baseline viral load, gender, and IL28B status, in the 6-week treatment arm. Additionally, 100%of patients (12/12) in the 8-week treatment duration arm have achieved SVR24. The combination of ACH-3102 and sofosbuvir was well-tolerated with no serious adverse events, no discontinuations due to adverse events, and no clinically significant laboratory or ECG abnormalities.

“The achievement of 100% SVR12 after 6 weeks of treatment with a dual NS5A-nucleotide 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 II program, which evaluates short 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.”

The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 150 million people are infected with HCV worldwide, including more than 5 million people in the US. Three-fourths of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death.

Achillion is seeking to apply its expertise in biology and structure-guided design and a deep understanding of patient and clinician needs to develop innovative treatment solutions aimed at improving patients’ lives. For more information, visit www.achillion.com.