The head of global research and executive vice president of Atara Biotherapeutics discussed the trial design of part 2 of the study of ATA188.
"We're developing this therapy for progressive MS, which is the most difficult-to-treat population of patients with MS. And as such, it really represents the greatest unmet need.”
Part 2 of a phase 1, multicenter study evaluating the safety/tolerability, product kinetics and biological and clinical effect of ATA188 (NCT03283826) in adults with progressive forms of multiple sclerosis (MS) is now underway.
The study design of the double-blind, placebo-controlled study was presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2021, February 25-27, by Amit Bar-Or, MD, FRCP, FAAN, FANA, professor and chief, MS division, Perelman School of Medicine, and director, Center for Neuroinflammation and Neurotherapeutics, and staff neurologist, University of Pennsylvania, and research scientist, Children’s Hospital of Pennsylvania.
Researchers will evaluate endpoints including incidence of adverse events, change from baseline in cerebrospinal fluid (CSF) immunoglobulin G index, change from baseline in clinical disability on expanded disability status scale, Timed 25-Foot Walk, and/or 9-hole peg test, ambulatory activity monitoring, cervical spinal cord volume and whole brain volume on magnetic resonance imaging, the number of gadolinium-enhancing and new or enlarging T2 lesions on brain MRI scans. Other exploratory endpoints include assessment of potential biomarkers such as oligoclonal bands in CSF, persistence of ATA188, and cytokine profiling in blood and CSF compartments.
NeurologyLive spoke with Jakob Dupont, MD, MA, head of global research and executive vice president, Atara Biotherapeutics, the company that is developing ATA188, to learn more about part 2 of the study of its investigational therapy.
For more coverage of ACTRIMS Forum 2021, click here.