TG Therapeutics recently announced the opening of a new clinical trial evaluating TG-1101, its glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing-remitting multiple sclerosis (RRMS).
The Phase 2 clinical trial, titled “A Placebo-Controlled Multi-Center Phase 2 Dose Finding Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients with Relapsing Forms of Multiple Sclerosis,” is being led by Edward Fox, MD, PhD, clinical assistant professor at the University of Texas Medical Branch in Round Rock, and director of the Multiple Sclerosis Clinic of Central Texas. The trial (NCT02738775), taking place in Round Rock and Phoenix, Arizona, is currently recruiting about 40 participants.
TG-1101 (ublituximab) is a novel monoclonal antibody designed to target a specific protein (CD20) found on mature B-lymphocytes. Although therapies for multiple sclerosis (MS) aiming at B-cell depletion have proven efficacious, this is the first company-sponsored trial evaluating TG-1101 for its safety, tolerability and efficacy in autoimmune diseases.
Particularly, the researchers will determine a TG-1101 optimal dose, focusing on decreasing infusion times, and at each dosing group they will monitor TG-1101 for safety, tolerability and B-cell depletion. Established MS efficacy endpoints will also be evaluated.
“We are excited to launch our first study in the treatment of patients with relapsing forms of MS, an area of significant unmet medical need. B-cell depletion therapy has recently proven to be highly effective in the treatment of both relapsing and progressive forms of MS,” Michael S. Weiss, the company’s executive chairman and interim chief executive officer said in a press release. “TG-1101 is a potent B-cell depleting agent; in our oncology studies TG-1101 has demonstrated an ability to cause rapid and profound B-cell depletion with a favorable safety profile. Additionally, early B-cell depletion data from our NMO study appears to confirm TG-1101’s potent B-cell depleting effects.
“This Phase 2 trial has been uniquely designed to evaluate rapid administration schedules for TG-1101, potentially allowing us to offer a very attractive and convenient treatment option for patients. We look forward to collaborating with Dr. Fox and the other investigators in this important study and launching a Phase 3 trial for TG-1101 in MS next year,” Weiss added.
Added Dr. Fox: “We look forward to collaborating with TG Therapeutics on this first clinical trial of TG-1101 in patients with relapsing forms of MS. An increasing amount of data strongly suggests a critical role for B-cells in the pathophysiology of MS. B-cell depletion therapy through the use of an anti-CD20 monoclonal antibody has the potential to offer a highly effective treatment option that has an acceptable safety and tolerability profile.”
TG Therapeutics specializes in developing therapies for autoimmune diseases and B-cell malignancies.