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TG Therapeutics Announces Data Presentations from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis Presented at the American Academy of Neurology Annual Meeting

Published: 2022-04-04 11:44:00 ET

NEW YORK, April 04, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data from the ULTIMATE I & II Phase 3 trials evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS), presented over the weekend at the American Academy of Neurology (AAN) annual meeting, held in Seattle, Washington. Highlights of the presentations are outlined below.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are pleased to present additional analyses from the ULTIMATE I & II trials, which continue to highlight encouraging data for ublituximab as a potential treatment for patients with relapsing forms of multiple sclerosis. Of note, post hoc/pooled analyses demonstrate approximately 95% of ublituximab treated patients who demonstrated 12-week CDI sustained the improvement through the end of the study at week 96, a consistent NEDA benefit for ublituximab-treated patients was demonstrated across treatment epochs and key patient subpopulations, and 96% of patients completed their ublituximab infusions without interruptions.” Mr. Weiss continued, “We believe these data reinforce the potential of ublituximab, if approved, to offer RMS patients a treatment option that can be administered in a one-hour infusion every six months after the first dose.”

Poster Presentation Title:Disability Improvements With Ublituximab in Relapsing Multiple Sclerosis (RMS): Expanded Disability Status Scale (EDSS), 9-Hole Peg Test (9-HPT), and Timed 25-Foot Walk (T25FW) Evaluations From the Phase 3 ULTIMATE I and II Studies

In pooled post hoc analyses of ULTIMATE I and II:
- Among ublituximab patients who demonstrated 12-week Confirmed Disability Improvement (CDI), 95.4% (62/65) sustained the improvement through the end of the study at week 96.
- In patients with a baseline Expanded Disability Status Score (EDSS) score ≥2.0, more patients in the ublituximab group than teriflunomide group had EDSS improvements of 1.0 and 1.5 points at Weeks 60, 72, 84, and 96 (P

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