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an FDA-approved drug for HIV, called maraviroc (Selzentry), made to hit one of the members of the chemokine receptor family, called CCR5. Others are in development, but no other company, Schall says, has attacked chemokine drug development in such a sweeping way against so many targets, and sustaining effort for such a long time.
“Others have had frustrations, and we think we understand that,” Schall says.
ChemoCentryx’s lead drug, developed in partnership with GlaxoSmithKline, is called Traficet-EN, and is made to hit a chemokine receptor called CCR9. Studies have shown that CCR9 is found mainly on T cells that migrate selectively to the intestines, where they can play a key role in the overactive inflammation found in people with Crohn’s disease and ulcerative colitis. An estimated 1.4 million Americans have Crohn’s or colitis. (Since I’m always looking for that Seattle angle in my hometown, I’ll have you know that Pearl Jam guitarist Mike McCready is a prominent Crohn’s spokesman.)
Schall wasn’t quite ready to talk about his company’s latest clinical results for Crohn’s when I stopped by his office in late September, but ChemoCentryx delivered some really interesting data just a week ago. A study of 436 patients, presented at a medical meeting in Barcelona, showed that half of patients with moderate-to-severe forms of Crohn’s who were randomly assigned to get the ChemoCentryx drug were in clinical remission after 36 weeks, compared with 31 percent on placebo. The company also reported on tests to show that CCR9 is active in both the small and large intestine, to offer more evidence of the underlying biology, which might help explain why patients on the drug appeared to be doing better.
This is still a preliminary finding, of course, meaning it’s not proof, it’s hypothesis-generating.
But the idea is interesting enough that GlaxoSmithKline is pushing ahead with a Phase III clinical trial expected to get underway by the end of this year, Schall says. “They saw the results, they loved the results, and now they are running with it,” he says.
The trial will be a big one, and more than a few other autoimmune disease drugs have failed at that stage. The study will have to enroll a lot … Next Page »
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