purified Omega-3 ethyl esters like GlaxoSmithKline’s (Lovaza) and Amarin’s (Vascepa), because early studies have shown that the Catabasis drug candidate might be able to significantly lower postprandial triglycerides—or those that build up in the blood after a meal.
“Really what you’re treating there is you’re trying to prevent the occurrence of pancreatitis, and it’s that postprandial triglyceride burst that can lead to bouts of pancreatitis,” Milne says. “That is a highly differentiated feature of [CAT-2003] that is not observed in the other agents that are currently marketed.”
This is important, because while Catabasis wants to see if CAT-2003 can show promise lowering triglycerides and cholesterol in patients with very high triglyceride levels (more than 500 milligrams/deciliter of blood)—a very competitive field—what it’s really after is “niche” triglyceride-related diseases that occur in those with more than 880 milligrams/deciliter of triglycerides in their blood. Catabasis says it’s areas like this where CAT-2003 has the chance to be a “first in disease” compound, according to Milne.
One of the disease types Catabasis is looking at, for instance, is familial or non-familial chylomicronemia syndrome (FCS), a rare disorder that makes it extremely difficult for patients to break down fats in the blood. There are no approved treatments for FCS in the U.S., but that doesn’t mean no one is trying to come up with one—San Diego, CA-based Isis Pharmaceuticals (NASDAQ: [[ticker:ISIS]]) is developing an injectable antisense drug for FCS, and just reported interim results from a mid-stage study in September.
Even so, Catabasis, whose drug is a pill, is taking its shot. It has two mid-stage studies ongoing. In the first, it is testing CAT-2003 with statins in patients with high cholesterol, and without statins in patients with very high triglycerides. It expects top-line results from that trial in the first half of 2014. The second study tests CAT-2003 in patients with significantly elevated triglyceride levels and chylomicronemia. That is expected to produce top-line results in the middle of 2014.
Catabasis has these studies to take care of, and to also decide whether to find a partner for CAT-1004, a drug it is developing for inflammatory bowel disease. Perhaps if Catabasis sees the results it’s looking for, it’ll end up on the IPO queue in 2014.
“First and foremost we have to deliver on this early pipeline,” Milne says.
