Catabasis Pharmaceuticals has a vision of combining the stuff you get in fish oil with a common anti-inflammatory. The idea is that the benefits of the whole might be greater than the sum of the parts. Today, the Cambridge, MA-based company is releasing the first data from clinical trials that suggests it is on the right track.
Catabasis is announcing today that its lead drug candidate, which uses a proprietary linker between an Omega-3 fatty acid (docosahexaenoic acid) and salicylate, was able to pass muster in a series of three Phase I clinical trials that enrolled a total of 105 people.
The drug was well-tolerated at a variety of doses, and inhibited 70 percent of the intended inflammatory biomarker in the blood (NF kappa B), says co-founder and CEO Jill Milne, adding that 50 percent inhibition is considered meaningful for rheumatoid arthritis patients. The drug also showed a synergistic effect in people, meaning that the combination was more effective at inhibiting NF kappa B than either of its component parts when given separately. Catabasis is reporting no serious side effects from the drug, although it did see some mild diarrhea at a 6-gram dose, higher than the dose the company intends to use in future trials, says Michael Jirousek, Catabasis’s chief scientific officer.
The findings are being released today at the BIO CEO & Investor Conference in New York, and are being prepared for a peer-reviewed publication and for a future scientific meeting, Milne says. Importantly, the data laid the groundwork for Catabasis to raise an additional $8.7 million, which it will use to build up its pipeline of other drug candidates, and advance CAT-1004 to the next steps of clinical trials for inflammatory bowel disease and Duchenne Muscular Dystrophy.
“We’re pleased with the results, and excited to see the potential of this molecule in further clinical trials,” Milne says.
Now that Catabasis has established its drug looks safe, and appears to hit its target of interest, it’s time to think about gathering data to show it helps patients. Catabasis originally talked up its drug for Type 2 diabetes, but the company is now focusing on other potential uses. Inflammatory bowel disease looks like a good place to start, Jirousek says, because ordinary salicylate is already used on its own to treat the disease, and CAT-1004 can be seen as “an amped-up version” of that well-known product.
Duchenne Muscular Dystrophy is different, because it’s a genetic disease that has prompted several companies to focus on treating the underlying genetic defect. In this case, Catabasis is hoping it can help boys with the muscle-wasting disorder by tamping down the excess inflammation that worsens their symptoms, with a drug that’s safer than typical corticosteroid immune suppressors.
Catabasis was founded in 2008 when Milne and Jirousek left Sirtris Pharmaceuticals around the time of its acquisition by GlaxoSmithKline. The startup now has 26 employees, and will be looking to hire “a few more,” as its lead drug advances further in clinical trials, Milne says.