H.C. Wainwright initiated coverage of Catabasis Pharmaceuticals (NASDAQ:CATB) with a “buy” rating and $14 price target. The stock closed at $3.59 on Dec. 21.
“The SMART Linker technology is key to our investment thesis,” writes analyst Carol Ann Werther.
Catabasis’ SMART Linker drug discovery platform is able to conjugate two separate bioactives with known pharmacological activity. The SMART Linker ensures the bioactives are not available in the circulation, improving safety and efficacy and may be superior to individual separate bioactives, she added.
Ms. Werther said the company has focused on NK-kB inhibition, an anti-inflammatory target, which has potential to modulate the progression of disease in many conditions. The lead indications are Duchenne muscular dystrophy (DMD) and cystic fibrosis (CF).
She said edasalonexent is an oral agent that has the potential to treat all 50,000 DMD patients in the developed world. It is a conjugate of salicylate and docosahexaenoic acid that down regulates the NF-kB pathway. “We are hopeful that edasalonexent will have the benefits of steroids, without the inhibition of muscle regeneration and the negative side effects.”
Part 1 of the MoveDMD trial showed safety and reduction of NF-kB levels in 17 DMD boys, with 16 of 17 patients enrolling in the Phase 2 portion of the trial. Similar reductions in NF-kB levels were seen in adults and edasalonexent has been shown to be well tolerated in over 100 subjects.
Top-line safety and efficacy of the MoveDMD Phase 2 trial is expected in the 1st half of the first quarter of 2017. Catabasis plans to use the totality of the data collected in this trial to plan and begin a pivotal trial in the second half.