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CAMBRIDGE, Mass. – November 19, 2015 – Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage drug development company built on a pathway pharmacology technology platform, today announced a collaboration to explore the potential utility of daily physiological activity monitoring in boys affected by Duchenne muscular dystrophy (DMD) with ActiGraph, a leading provider of objective physical activity and sleep/wake measurement solutions for the global scientific community. Catabasis is launching a new observational trial to measure the daily physical activity of patients affected by Duchenne.
The trial is designed to monitor the activity of young boys who are affected by Duchenne and collect baseline and longitudinal data using ActiGraph activity monitoring devices. The ActiGraph monitor uses an accelerometer to continuously measure movement, and these data can be analyzed to measure steps and intensity of motion. Catabasis is currently conducting the MoveDMDSM Phase 1 / 2 clinical trial of CAT-1004 in 4-7 year-old boys affected by Duchenne. We expect that the observational trial will enroll patients that have completed Part A of the MoveDMD trial. Patients enrolled in this observational trial will receive an ActiGraph activity monitor to be worn for 1 week each month. Catabasis plans to analyze the data collected and explore the findings from monitoring the daily physical activity of patients with DMD.
“We at Catabasis are committed not only to developing treatments for Duchenne; we are also committed to moving the field forward by exploring the development of non-invasive approaches that measure daily activities to help assess quality of life for patients with Duchenne,” said Joanne Donovan, Chief Medical Officer of Catabasis Pharmaceuticals. “Our hope is that what we learn through the use of the ActiGraph monitors may eventually have the potential to make the trial participation more impactful for patients and their families.”
Christine McSherry, Executive Director of the Jett Foundation, an organization dedicated to increasing worldwide awareness of DMD, added, “It is extremely exciting to see companies applying innovative technology to discover new approaches to patient evaluation and activity assessment in DMD. We applaud both Catabasis and ActiGraph for their forward thinking and constant consideration of the impact clinical trial participation has on Duchenne families.”
CAT-1004 is an oral small molecule that inhibits activated NF-kB, a protein that coordinates cellular response to muscular damage, stress and inflammation and plays an important role in muscle health. In skeletal muscle, activated NF-kB drives muscle degeneration and suppresses muscle regeneration. In animal models of DMD, CAT-1004 inhibited activated NF-kB, reduced muscle inflammation and degeneration and increased muscle regeneration. In Phase 1 clinical trials, CAT-1004 inhibited activated NF-kB and was well tolerated with no observed safety concerns. The FDA has granted CAT-1004 orphan drug, fast track and rare pediatric disease designations for the treatment of DMD. Catabasis is currently conducting the MoveDMD Phase 1 / 2 trial of CAT-1004 in 4-7 year-old boys with DMD.
ActiGraph’s suite of validated hardware and software products are widely used by prominent scientific, academic, and pharmaceutical organizations in more than 75 countries in research studies and clinical trials involving physical activity, energy, expenditure, and sleep/wake behavior and their relationships to a wide range of health conditions including obesity, diabetes, cancer, CNS disorders, cardiovascular disease, and sleep disorders. ActiGraph activity measurement solutions have delivered objective data to many high profile population studies including the National Health and Nutrition Examination Survey (NHANES), the Harvard Women’s Health Study, the German National Cohort, and the U.K. Millennium Cohort Study. ActiGraph’s activity monitors are available for prescription use only. ActiGraph’s activity monitors are small worn activity monitors designed for documenting physical movement associated with applications in physiological monitoring.
Catabasis Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics using its proprietary Safely Metabolized And Rationally Targeted, or SMART, linker technology platform. The Company’s SMART linker technology platform is based on the concept of treating diseases by simultaneously modulating multiple targets in one or more related disease pathways. The Company engineers bi-functional product candidates that are conjugates of two molecules, or bioactives, each with known pharmacological activity, joined by one of its proprietary SMART linkers. The SMART linker conjugates are designed for enhanced efficacy and improved safety and tolerability. The Company’s focus is on treatments for rare diseases. The Company is also developing other product candidates for the treatment of serious lipid disorders. For more information on the Company’s technology and pipeline of drug candidates, please visit www.catabasis.com