The National Multiple Sclerosis Society and Critical Path Institute (C-Path) together launched the Multiple Sclerosis Outcome Assessments Consortium (MSOAC). The goal of this coalition of industry, academia, patient representatives, regulatory agencies, and the National MS Society is to develop new standards for assessing outcomes in clinical trials of MS therapies. The MSOAC will collect, standardize, and analyze data from MS studies with the aim of qualifying a new clinician-reported outcome measure of disability as a primary endpoint for future MS trials.
“Robust clinical outcome measures are greatly needed to evaluate new treatments for MS,” says Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The consortium approach pioneered by FDA and C-Path will facilitate a combination of available data and expertise to generate the best possible drug development tool.”
Forming consortia to accelerate drug treatment development is a new strategy employed by disease foundations in achieving their mission, according to the National MS Society. “The Society recognized the gap in the MS treatment pipeline, and seized the opportunity to bring together the stakeholders needed to move the field forward in this way,” indicates Cynthia Zagieboylo, president and CEO at the National MS Society.
The new clinical outcome measure aims to spur the development of therapies for all forms of MS. “Presently there are no treatments for the progressive forms of MS, and it’s difficult to detect changes as the disease gradually takes its toll,” emphasizes Richard Rudick, M.D., director of the Mellen MS Center at the Cleveland Clinic Foundation and a co-leader of the new consortium. “A sensitive clinical outcome measure of disability would address this unmet need.”
The National MS Society's translational research subsidiary Fast Forward has been forging collaborations and alliances as well, including one in November with DioGenix to develop a new blood test for MS; one in October with Ezose Sciences focused on applying the latter’s GlycanMap® technology to identify MS biomarkers for disease diagnosis, differentiating subtypes of the disease, and aiding in disease management; and one in March with Concert Pharmaceuticals to fund preclinical development of Concert’s deuterium-modified subtype–selective GAGAA modulator, C-21191, for the potential treatment of spasticity and pain in MS.