After Jill Milne and Michael Jirousek left their positions at Sirtris Pharmaceuticals in 2008, they decided to pursue a titillating but still largely unproven idea: that fighting inflammation might help control Type 2 diabetes. On October 5, their startup, Cambridge, MA-based Catabasis Pharmaceuticals, began to test that theory in humans for the first time, with the initiation of a clinical trial of the company’s lead drug, CAT-1004.
Catabasis created the drug by combining two well-known types of anti-inflammatory compounds: salicylate and omega-3 fatty acids, which are typically found in fish oil. While the founders don’t expect their drug will replace commonly used diabetes treatments such as metformin, they believe it could be an important add-on. Inflammation has been linked with insulin resistance and the spiraling complications of diabetes such as heart diseases and blindness. “Inflammation in Type 2 diabetes is one of the hottest areas being looked at today, because if you were able to safely and effectively target it, you would produce disease modification,” says Jirousek, chief scientific officer of Catabasis.
The company’s first study is designed to measure the safety of CAT-1004, as well as its “pharmacokinetics,” such as how its absorbed and distributed in the body. If all goes well, the company could initiate a Phase 2 study next year, says Joanne Donovan, Catabasis’ chief medical officer. Although the earliest studies will test CAT-1004 in isolation, later studies will likely include patients who are taking metformin and other therapies, but still don’t have their glucose under control, she says.
Catabasis raised $39.6 million last spring from SV Life Sciences, Clarus Ventures, Advanced Technology Ventures (ATV), and Medimmune Ventures. Milne, who is Catabasis’ CEO, says that’s enough to take CAT-1004through a Phase 2 program. “Our options are to raise another round in 2013 or to close a partnership,” she says.
Catabasis’ preference, Milne indicates, is to find a development partner for CAT-1004. “Even at this early stage we’ve seen some significant interest,” she says. “The potential to produce disease-modifying therapies is what’s driving that.”
Bringing on a partner to help develop CAT-1004 will be especially important at a time when the FDA is cracking down on companies developing diabetes compounds. In the wake of criticism over the approval of GlaxoSmithKline’s rosiglitazone (Avandia)—which has been linked to heart risks—the FDA in 2008 issued tough new guidelines for diabetes drug developers, including a mandate that they perform large trials to rule out cardiovascular risks.
Those guidelines have made it extraordinarily difficult for startups to finance their own Type 2 diabetes trials. Witness the saga of San Diego-based Phenomix: Last October it shut down after the estimated cost of developing its Type 2 diabetes program doubled and its Big Pharma partner, Forest Laboratories, bailed.
Milne says she anticipates that any Big Pharma company that’s interested in CAT-1004 is going to want to take a leading role in designing late-stage clinical studies, to ensure the FDA will get on board. “Our goal right now is to identify the partner that we think shares the vision of the program and really sees the potential of it,” she says. “We want a partner that’s going to take this compound the entire way.”
Meantime, Catabasis is starting to put together a pipeline of anti-inflammatory drugs to treat a host of other diseases. It is investigating the potential of CAT-1004 in inflammatory bowel disease and rheumatoid arthritis. It’s also developing novel compounds to treat high triglycerides and multiple sclerosis.
Milne and Jirousek say they’re not aware of other companies working on derivatives of anti-inflammatories, though there are some startups testing purified omega-3 fatty acids. They include Ireland-based Amarin (NASDAQ: AMRN) and Beminster, NJ-based Omthera Pharmaceuticals. Says Jirousek, “There’s a huge amount of interest in understanding the biological activity of omega-3s, as well as their therapeutic potential.”
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