Allozyne can’t be accused of thinking too small. The Seattle-based startup, after taking a hard look at its first clinical trial, is daring to push ahead with a frontal attack on the world’s largest maker of multiple sclerosis drugs, Weston, MA-based Biogen Idec (NASDAQ: BIIB).
The challenger’s experimental treatment, a long-lasting injection for multiple sclerosis, was safe and well-tolerated at all three doses in its first study in 40 healthy volunteers. Allozyne’s drug, importantly, stayed active in people’s bloodstreams for about 14 days at a high and medium dose, which means Allozyne has a shot at making a product that MS patients could inject themselves once a month, instead of once or twice a week as they do today. The company is releasing the results today in the hopes of wowing Big Pharma dealmakers and venture capitalists gathered in San Francisco for the JP Morgan Healthcare Conference.
There’s no cure out there for multiple sclerosis, a disease in which the immune system goes haywire, attacking nerve cells, and ultimately robbing patients of their vision, speech, and their ability to walk. More than 400,000 patients in the U.S. have this chronic disease. What drug companies know is that many people can keep symptoms at bay for years with interferon-beta products which tamp down the immune system. The interferons—marketed as Biogen Idec’s Avonex, Merck KGaA’s Rebif, and Bayer’s Betaseron—generate billions in sales. But they don’t stop the progressive march of the disease, and patients often complain about all the injections they must endure.
That has created intense interest over the years in making a longer-lasting form of interferon. Allozyne—and Biogen Idec, the market leader—have both hit upon the same idea, combining the interferon beta molecule with a polymer that’s supposed to keep it stable in the bloodstream for a longer period of time. Even though Biogen had a big head start and ought to have the first mover advantage, CEO Meenu Chhabra says she is emboldened to challenge Biogen in this market now that she has clinical trial data, and a plan to take it the rest of the way through clinical trials to the market.
“Allozyne is no longer just an Accelerator graduate with an interesting platform technology,” Chhabra says. “We’re a clinical stage company with a pipeline of products. It’s an evolution.”
OK, so what did we really learn from the first clinical trial? I have to say a healthy grain of salt here is required, because these results haven’t been presented in a peer-reviewed journal or at a scientific conference.
Chhabra walked me through the trial results last night, and what it means strategically, along with Bruce Leuchter, the director of clinical neuropsychiatry at Weill Cornell Medical College in New York, and a member of Allozyne’s clinical advisory board.
The Allozyne study found that its drug, AZ01, given via an injection just under the skin, was well-tolerated—although there were some flu-like symptoms at the highest dose tested, Chhabra says. The drug lasted about 14 days in the bloodstream, at both a 3 milligram dose, and a 10 milligram dose, although the lower dose produced a more steady, stable concentration, Chhabra says. The Allozyne study wasn’t designed to answer any important questions about effectiveness—like its impact on brain lesions, MS flares, or ability to keep patients from becoming disabled.
While the Allozyne trial didn’t directly compare its drug … Next Page »
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