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FDA maintains clinical hold for sovaprevir

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The FDA will not remove a clinical hold placed on sovaprevir, an NS3 protease inhibitor in development for the treatment of chronic hepatitis C, according to a press release.

The hold was placed in July, following the incidence of significantly elevated ALT among patients exposed to sovaprevir (Achillion Pharmaceuticals) in a phase 1 drug-drug interaction study assessing the effects of its use with atazanavir. The FDA requested additional data from two DDI studies of sovaprevir and safety analysis from ongoing trials of the drug. According to the release, the clinical hold will continue despite the company’s response to FDA concerns.

The company also announced interim results from a phase 2a double blind trial assessing efficacy, safety and tolerability of a 12-week regimen of sovaprevir, ACH-3102 and ribavirin among 50 treatment-naive patients. In the initial phase, 30 patients were randomly assigned placebo or 200 mg or 400 mg sovaprevir daily, along with a 50-mg daily dose of ACH-3102 (preceded by a 150-mg loading dose) and two daily ribavirin doses. All participants had HCV RNA below 25 IU/mL within 2 weeks of treatment, and 79% of patients with HCV genotype 1 had levels below 10 IU/mL after 4 weeks. No serious adverse events related to treatment had been observed as of the announcement; no patients had experienced graded ALT or AST increases.

“While we are disappointed that we were not able to resolve the clinical hold at this time despite having addressed all the issues, we believe the breadth of our portfolio allows us to quickly advance other all-oral combination regimens for the treatment of HCV,” Milind Deshpande, PhD, Achillion president and CEO, said in the release. “With our phase 2 NS5A inhibitor, ACH-3102, we are in a position to rapidly initiate combination studies with ACH-2684, our protease inhibitor, with results expected in 2014. Further, we continue to advance our uridine-analog nucleotide, ACH-3422, with which we anticipate initiating clinical trials in the first half of 2014.”