Catabasis Pharmaceuticals Inc (NASDAQ:CATB) rebounded from 2 year lows today. By mid session share hit 2.38 up 68% and for good reason. The company reported positive results from a key clinical trial. This led to excitement among investors, sending the stock up sharply.
CATB Gains On Strong Clinical Results
As mentioned above, Catabasis is having an incredibly strong day in the market today after reporting strong clinical results from a key trial. In a press release, early this morning, the company reported positive efficacy and safety results surrounding a Duchene muscular dystrophy, or DMD, clinical trial. The trial, known as MoveDMD, was an open label extension that followed 48 and 60 weeks of treatment with the company’s drug candidate, edalonexent.
CATB said that improvement in all assessments of muscle function were observed after more than one year of oral 100 mg/kg/day edasalonexent treatment when compared to the rates of change in the pre-specified control period for boys prior to receiving edasalonexent treatment. On top of the data mentioned above, other supportive changes were seen. Supportive changes in non-effort based measures of muscular health and significant longer-term reductions in muscle enzymes and C-reactive protein were seen. This ultimately supports the durability of edasalonexent treatment effects.
In the press release, CATB said that the treatment continued to be well tolerated with no safety signals observed in the trial. The company said that it will be presenting the data on Saturday, February 17, 2018 at the XVI International Conference on Duchenne and Becker Muscular Dystrophy in Rome, Italy.
As a result of the strong data, Catabasis (NASDAQ:CATB) now has plans to initiate a Phase 3 trial. The company said that it plans on initiating a single global Phase 3 trial, assessing edasalonexent in patients with DMD, regardless of mutation type. It is expected that this trial will launch in the first half of 2018 and that top-line results will be available in 2020. In a statement, Jill C. Milne, Ph.D., CEE at CATB, had the following to offer:
We are thrilled to see this preservation of muscle function and substantial slowing of disease progression in boys following more than a year of edasalonexent treatment. This effect has the potential to be extremely impactful for boys affected by Duchenne… Building on the results previously reported for edasalonexent treatment in patients up to 36 weeks, these new data at 48 and 60 weeks show that edasalonexent continued to slow progression of the disease. We look forward to advancing edasalonexent in a single global Phase 3 trial later this year with the goal of improving the quality and length of life for those affected by Duchenne.