A little more than a year after Vertex licensed in a pair of "nucs" from Alios BioPharma in a high-stakes bid to develop an oral, interferon-free approach to hepatitis C, Vertex ($VRTX) is jettisoning one as a dud while racing ahead with the second into a mid-stage study slated to begin in a matter of weeks.
Vertex paid $60 million upfront in a $1.5 billion package of promises for ALS-2200 and ALS-2158, which represent Vertex's best and biggest hope for staying on top of the growing market for hepatitis C drugs. But the antiviral activity for 2158 fizzled in an early study, leaving Vertex focused on the clinical response it's been seeing for 2200--a uridine nucleotide analogue.
Investigators say they were encouraged by a "reduction from baseline in HCV RNA after seven days of dosing with a once-daily 200 mg dose of ALS-2200 in combination with ribavirin in people with genotype 1 chronic hepatitis C who were new to treatment." Vertex's plan now is to swiftly execute on a mid-stage study of ALS-2200 combined with Incivek, its pioneering therapy. And the biotech notes that its deal with Alios includes the hunt for additional therapies.
"Our goal is to develop all-oral regimens that are well-tolerated and provide a high rate of viral cure in a broad population of people with chronic hepatitis C," said Robert Kauffman, the chief medical officer at Vertex. "We're making good progress and expect to begin all-oral Phase II combination studies by the end of this year."
Vertex has plenty of competition in this field, which seems strewn with clinical landmines. Bristol-Myers Squibb's $2.5 billion acquisition of Inhibitex's lead drug ended in disaster, with one patient from a trial dead and several others temporarily hospitalized. Idenix has been at least temporarily stymied as regulators consider whether its programs also threaten patients. And Gilead, Abbott and Achillion are all hard at work on their own candidates.
- here's the press release
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