TG Therapeutics and the U.S. Food and Drug Administration (FDA) have agreed on a special protocol assessment for a Phase 3 trial program evaluating TG-1101 (ublituximab) to potentially treat relapsing forms of multiple sclerosis (MS).
A special protocol assessment (SPA) is a procedure by which the agency officially evaluates the design and size of proposed protocols meant to ground a new drug application (NDA). The SPA marks the conditions under which the trial design adequately addresses objectives that, if met, will support consequent regulatory submission for approval of TG-1101.
Stanford University’s Dr. Lawrence Steinman will lead the program, which is expected to begin this year. It includes two Phase 3 clinical trials (ULTIMATE I and ULTIMATE II) — both randomized, double-blind, active-controlled studies comparing TG-1101 to Aubagio (teriflunomide) in patients with relapsing MS.
TG-1101 is TG’s novel glyco-engineered monoclonal antibody that targets a specific and unique epitope on the CD20 protein found on mature B-cells. The primary endpoint of the trials will be changes in annualized relapse rate after 96 weeks of treatment in about 440 randomized patients in each trial.
“B-cell targeted therapy with anti-CD20 monoclonal antibodies has been shown to be very active in the treatment of multiple sclerosis, and with the recent approval of ocrelizumab, we have entered a new era of B-cell targeted therapy for MS,” Steinman said in a press release.
“The Phase 2 data recently presented for ublituximab demonstrates an encouraging safety and efficacy profile in the treatment of MS with this novel glyco-engineered anti-CD20 monoclonal antibody,” said Steinman. “We believe the unique attributes of ublituximab — in particular the rapid infusion times and potential pricing advantages — may provide added convenience and enhance patient care and access over currently available therapies.”
Michael S. Weiss, TG’s executive chairman and CEO, said the New York-based pharma company hopes this Phase 3 program “will establish TG-1101 as an important new drug” in the treatment of MS.
“The early data from our Phase 2 clinical trial, the highly successful pivotal results for the anti-CD20 monoclonal antibody ocrelizumab in MS, and the substantial safety data generated in our oncology program, gives us a high level of confidence in the potential for a successful outcome,” he said. “We look forward to enrolling our first patient before the end of the summer.”