- Completed enrollment in Phase 2 (Part B) of the MoveDMD trial of edasalonexent in October. Top-line safety and efficacy results from the placebo-controlled portion of the MoveDMD trial are expected in the first half of Q1 2017.
- Presented positive biomarker gene expression and proteomic data from Part A of the MoveDMD trial of edasalonexent at the World Muscle Society Congress.
- Announced the initiation of an open-label extension for the MoveDMD trial, in which patients will continue on open-label edasalonexent for 36 weeks following completion of the 12-week, placebo-controlled portion of the trial. During the open-label extension, safety will be monitored and additional assessments including MRI, timed function tests, muscle strength measures, the North Star Ambulatory Assessment and the pediatric outcomes data collection instrument (PODCI) will be performed.
- Announced a joint research collaboration with Sarepta Therapeutics to explore a combination drug treatment approach for DMD. The two companies will contribute their respective expertise to study edasalonexent, an oral NF-kB inhibitor, developed by Catabasis, together with an exon skipping treatment developed by Sarepta in a mouse model of DMD.
- Presented positive preclinical data for CAT-5571, a potential therapy to treat cystic fibrosis (CF), at the North American Cystic Fibrosis Conference. CAT-5571, an activator of autophagy, in combination with lumacaftor/ivacaftor, enhanced cell-surface trafficking and function of cystic fibrosis transmembrane conductance regulator (CFTR) in bronchial epithelial cells from CF patients with the F508del mutation. Catabasis also demonstrated that CAT-5571 enhanced the clearance of Pseudomonas aeruginosa infection in preclinical models of CF, irrespective of CFTR mutation status.
- Continued CAT-4001 preclinical program research in rare neurodegenerative diseases. Preclinical activities exploring the potential of CAT-4001 in diseases such as amyotrophic lateral sclerosis (ALS) and Friedreich's ataxia are ongoing.
- Catabasis will host its first Investor Day in New York on November 17, 2016, focused on its strategy in rare diseases and the pipeline, including edasalonexent and other programs. The Investor Day is open to members of the professional investment community. For more information or to register, please email CATB@macbiocom.com.
- In September 2016, Catabasis sold 2,875,000 shares of common stock in an underwritten registered direct offering at a price of $4.00 per share and generated net proceeds of $10.6 million. During third quarter 2016, Catabasis sold 368,015 shares under an at-the-market offering program for net proceeds of $1.3 million.
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