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TG Therapeutics Announces Presentation of Exploratory Analyses from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis Presented at the 2022 European Committee for Treatment and Research in Multiple Sclerosis

Published: 2022-10-26 11:30:00 ET
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NEW YORK, Oct. 26, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced presentations highlighting exploratory analyses from the ULTIMATE I & II Phase 3 trials evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS), presented at the 2022 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting. Links to each of the presentations are included below.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are excited to share additional exploratory analyses from the ULTIMATE I & II Phase 3 trials at the ECTRIMS conference this week. We believe the data continue to show an encouraging profile for ublituximab to treat patients with RMS, if approved, and look forward to our upcoming PDUFA goal date of December 28, 2022.”

PRESENTATIONS: Poster Presentation:Disability Changes in the Absence of Relapse in the Phase 3 ULTIMATE I and II Studies of ublituximab Versus teriflunomide in Participants With Relapsing Multiple Sclerosis

  • Lead Author: Sibyl Wray, MD Hope Neurology, Knoxville, TN

Poster Presentation:Functional systems scores and expanded disability status scale score evaluations in the ULTIMATE I and II studies of ublituximab versus teriflunomide in participants with relapsing multiple sclerosis

  • Lead Author: Bruce A. C. Cree, MD, PhD, MAS, UCSF Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA

Poster Presentation:Ublituximab treatment is associated with a significant proportion of patients achieving NEDA-4

  • Lead Author: Enrique Alvarez, MD, University of Colorado, Aurora, CO

Poster Presentation:Disease Outcomes With ublituximab in Treatment-Naive Participants: Subpopulation Analyses of the Phase 3 ULTIMATE I and II Studies in Participants With Relapsing Multiple Sclerosis

  • Lead Author: Lawrence Steinman, MD Stanford University, Stanford, CA, USA

Poster Presentation:B-Cell Depletion and Return in Participant Subgroups of the Phase 3 ULTIMATE I and II Studies of ublituximab Versus teriflunomide in Participants With Relapsing Multiple Sclerosis

  • Lead Author: Edward J. Fox, MD, PhD, Central Texas Neurology Consultants, Round Rock, TX

The above presentations are also available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm

ABOUT THE ULTIMATE I & II PHASE 3 TRIALSULTIMATE I and ULTIMATE II are two independent Phase 3, randomized, double-blinded, active-controlled, global, multi-center studies evaluating the efficacy and safety/tolerability of ublituximab (450mg dose administered by one-hour intravenous infusion every 6 months, following a Day 1 infusion of 150mg over four hours and a Day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in subjects with relapsing forms of Multiple Sclerosis (RMS). The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University and were conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). As previously announced, both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) compared to teriflunomide over a 96-week period (p