Catabasis Pharmaceuticals (CATB) continues to make solid progress for its phase 3 PolarisDMD as it continues to complete enrollment across the globe. Data from this late-stage study is anticipated to be released by the second half of 2020. If all goes well, then the biotech will be able to file an NDA for FDA approval by early 2021. A prior phase 2 study using edasalonexent to treat patients with duchenne muscular dystrophy (DMD) showed that patients were able to see an increase in the North Star Ambulatory Assessment (NSAA) score compared to placebo. This is notable because the phase 3 study has been established with the very same primary endpoint efficacy outcome measure. This catalyst provides a major inflection point for this biotech and its investors in the coming year.
Screening Of Patients Nears Completion And Readout Remains On Track
The phase 3 PolarisDMD study continues to screen in multiple countries including United States, Canada, United Kingdom, Australia, and several others. While screening is moving along in those countries, there are several countries that are no longer accepting any new patients. These countries are: Ireland, United Kingdom, Germany, Sweden, Ireland, and Israel. The quick enrollment is quite impressive in my opinion, especially when you consider that DMD is a rare disease. The reason why I like Catabasis is because edasalonexent treats all boys that are affected with DMD, regardless of mutation type. This allows the biotech to go after the entire population of DMD patients and not just a subset of it. Data from an open-label phase 2 study was quite successful. That's because treatment with edasalonexent compared to an off-treatment control time period showed that patients treated with drug had preserved muscle function and slowed DMD progression. DMD progression was slowed in all four muscle function tests which were:
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