Achillion HCV program back on track, as FDA lifts sovaprevir study hold; initiates ACH-3422 dosing

US drugmaker Achillion (Nasdaq: ACHN) has begun dosing ACH-3422, a uridine-analog nucleotide polymerase inhibitor, for seven days in patients with genotype 1 chronic hepatitis C viral infection (HCV) in its ongoing Phase I clinical trial. Proof-of-concept results from this trial are expected to be reported during the fall of 2014.

Furthermore, Achillion announced today that the US Food and Drug Administration has removed the clinical hold on sovaprevir, an NS3/4A protease inhibitor, to permit the conduct of trials in patients with HCV. The FDA’s clinical hold was applied after elevations in liver enzymes associated with significantly higher than anticipated exposures to atazanivir and sovaprevir were noted in a  Phase I healthy subject drug-drug interaction (DDI) study evaluating the effects of concomitant administration of sovaprevir with ritonavir-boosted atazanavir.

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