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FDA Lifts Clinical Hold on Sovaprevir; Phase 2 Trials Move Forward
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Achillion Pharmaceuticals will continue to conduct phase 2 trials using the protease inhibitor sovaprevir to treat patients with hepatitis C virus after the FDA announced that it partially lifted a clinical hold on the drug.
The FDA removed the hold, allowing researchers to resume therapeutic trials with a maximum of 200 mg sovaprevir per day in patients with HCV and in single-dose trials in healthy patients. The FDA 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, according to a press release.
The FDA hold was applied last year when elevated liver enzymes were detected in patients assigned sovaprevir, an NS3/4A protease inhibitor, in combination with atazanavir and ritonavir in a phase 1 study.
Sovaprevir was developed as a therapy for patients with chronic HCV. Approximately 550 patients already have been treated with the drug in two phase 2 studies with 12-week treatment programs. One study included treatment with sovaprevir combined with pegylated interferon and ribavirin, and the other monitored the use of sovaprevir in combination with ACH-3102, Achillions second-generation NS5A inhibitor. In the second study, all of the patients with HCV genotype 1b achieved sustained virologic response.