TG Therapeutics, FDA Agree on Phase 3 Program to Evaluate Relapsing MS Therapy TG-1101 – Multiple Sclerosis News Today

TG Therapeuticsand 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 treatrelapsing 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 Universitys Dr. Lawrence Steinman will lead the program, which is expected to begin this year. Itincludes 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.

By targeting relapsing MS, TG-1101 could potentially be approved to two particular forms of the disease:relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS), which often follows RRMS.

TG-1101 is TGs novel glyco-engineered monoclonal antibody that targets a specific and unique epitope on the CD20 proteinfound on mature B-cells. The primary endpoint of the trials will be changes inannualized 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.

Ocrevus (ocrelizumab) is a humanizedmonoclonal antibody that targets B-cells with the CD20 molecule. The FDAapprovedit on March 28, 2017,as an MS treatment.

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, TGs 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.

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TG Therapeutics, FDA Agree on Phase 3 Program to Evaluate Relapsing MS Therapy TG-1101 - Multiple Sclerosis News Today