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TG Therapeutics Announces Presentation of Exploratory Analyses from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis at the 8Th Congress of the European Academy of Neurology

Published: 2022-06-27 11:30:00 ET
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NEW YORK, June 27, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data presentations highlighting data from pooled and post hoc analyses of the ULTIMATE I & II Phase 3 trials evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS), presented at the 8th Congress of the European Academy of Neurology (EAN). Links to the presentations are included below.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are encouraged by the findings from these additional exploratory analyses of the ULTIMATE I & II Phase 3 trials, which reinforces our belief in the potential of ublituximab in the treatment of relapsing forms of multiple sclerosis. As a company, our primary focus remains on obtaining FDA approval of ublituximab by December 28, 2022, the PDUFA goal data.”ePoster Presentation:Ublituximab Efficacy Outcomes in Relapsing Multiple Sclerosis Patient Subgroups in the ULTIMATE I and II Studies

  • Lead Author: Hans-Peter Hartung, MD, Heinrich Heine University, Dusseldorf, Germany

ePoster Presentation:Improved Quality of Life With Ublituximab in the ULTIMATE I and II Studies in Relapsing Multiple Sclerosis

  • Lead Author: Krzysztof Selmaj, MD, PhD, Center of Neurology, Lodz, Poland

ePoster Presentation:Disability Improvements With Ublituximab in Relapsing Multiple Sclerosis: Pooled Post Hoc Analyses of the ULTIMATE I & II Studies

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

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