Achillion Reports 100 Percent SVR12 in Phase 2 Trial

Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) announced that all of the 12 patients that participated in a Phase 2 trial aimed at testing “the efficacy, safety, and tolerability of six weeks of 50 mg of ACH-3102 and 400 mg of sofosbuvir” achieved sustained viral response 12 weeks (SVR12).

As quoted in the press release:

This ongoing study is a Phase 2 open-label, randomized, partial-crossover study to evaluate the efficacy, safety, and tolerability of eight- and six 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, eighteen patients were enrolled, including six observational patients, into an eight-week treatment cohort.

Following the achievement of 100 percent SVR12 (12/12) in the eight-week cohort, the six-week treatment cohort was initiated. In all, eighteen patients were enrolled, including twelve active and six 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 seven patients with baseline HCV RNA viral load exceeding 6 million (6.78 log₁₀) IU/ml. Of the 12 active patients enrolled, seven patients were genotype 1a and five were genotype 1b.

Twelve weeks after the completion of therapy, 100 percent (12/12) achieved SVR12, independent of baseline viral load, gender, and IL28B status, in the six-week treatment arm. Additionally, one hundred percent of patients (12/12) in the eight-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.

Click here to read the full Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) press release.