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through 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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