A year ago buzz about a potential Achillion buyout ($ACHN) was all the rage as big biopharma rivals jostled for the inside track in a multibillion-dollar race through the clinic with next-gen hepatitis C therapies. But as some programs either crashed and burned or were forced to the side of the track by anxious regulators, the buzz--and Achillion's inflated share price--faded. Today, Achillion got a little of that old luster back is it produced some promising early-stage, proof-of-concept data on a closely-watched NS5A inhibitor. And the numbers helped reveal that despite the setbacks, the clinical race is still very much on.
Just three months after Achillion started a Phase Ia study for ACH-3102, which was used for a classic safety check, investigators ramped up a Ib trial with 14 patients. Today it reported that the NS5A inhibitor, billed as a next-gen competitor for the oral, interferon-free combo treatments now in the clinic, produced a significant reduction in viral load after a range of single doses were tested. A mean maximum 3.74 log reduction in HCV RNA was recorded for genotype 1a patients, with resistant variants also responding.
With the 14-day efficacy results completed, Achillion has already jumped into a 12-week Phase II study of 3102 combined with ribavirin for genotype 1b. And investigators will test the sustained virologic response level, with that data coming in the fourth quarter of this year. Altogether, Phase Ia through an initial Phase II is being executed in less than five months, a pace rarely matched in the slow-moving drug development. Achillion also has its lead NS3 protease, ACH-1625 (sovaprevir), in mid-stage studies.
"With the initiation of this all-oral 12-week study evaluating ACH-3102 and ribavirin for the treatment of HCV genotype 1b, we have rapidly advanced our portfolio and believe the attributes of ACH-3102, as well as sovaprevir, our Phase 2 protease inhibitor, have the potential to provide optimized compounds for the broad treatment of HCV," noted Achillion CEO Michael Kishbauch in a statement.
All the competitors in this race have been revving up the clinical trial process in hopes of becoming the first to gain an approval for an interferon-free approach. But the go-fast strategy isn't without critics. Bristol-Myers Squibb ($BMY) has been accused of recklessly ignoring red flags after it rushed into studies for a newly-acquired "nuc" from Inhibitex, which was linked to the death of one patient and the severe injury of several more.
- here's the press release
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