TG Therapeutics completes Enrollment for Ublituximab in MS trial

TG Therapeutics announced that target enrollment in the ULTIMATE I and II Phase 3 trials has been achieved. ULTIMATE I and II are two independent Phase 3 clinical trials evaluating the safety and efficacy of ublituximab (TG-1101), the Company’s glycoengineered anti-CD20 monoclonal antibody, as compared to teriflunomide, in patients with relapsing forms of Multiple Sclerosis (RMS). These studies are being led by Dr. Lawrence Steinman, of Stanford University and are being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). While target enrollment has been reached, in order to provide an opportunity for patients already identified to participate, enrollment is expected to continue until mid-September.

Michael S. Weiss, Executive Chairman and Chief Executive Officer, stated, “We are extremely pleased to have achieved target enrollment in the ULTIMATE Phase 3 trials approximately 9 months ahead of originally anticipated, which may enable an accelerated readout of the results possibly as early as the middle of 2020.” Mr. Weiss continued, “We’ve presented several early cuts of data from our Phase 2 MS trial of ublituximab at key conferences over the last year and believe the safety and activity demonstrated thus far support our belief that the ULTIMATE Phase 3 studies will be positive. We look forward to presenting the final data from our Phase 2 MS study at a major medical conference before year end. With the Phase 3 MS studies completing enrollment earlier than expected, we now have multiple pivotal data read-outs projected to occur between now and mid-2020 from both our cancer and MS programs.”

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News Source: TG Therapeutics website

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