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TG Therapeutics Announces Data Presentations from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis to be Presented at the 2022 European Committee for Treatment and Research in Multiple Sclerosis

Published: 2022-10-13 11:30:00 ET
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NEW YORK, Oct. 13, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of data presentations, highlighting data from the ULTIMATE I & II Phase 3 trials evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS), at the upcoming 2022 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, being held October 26 – 28, 2022, in Amsterdam, the Netherlands. Abstracts are now available online and can be accessed on the ECTRIMS meeting website at https://journals.sagepub.com/doi/epub/10.1177/13524585221123687. Details of the presentations are outlined below. PRESENTATIONS: Poster Presentation Title: 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

  • Presentation Date/Time: Wednesday, October 26, 2022 / 16:30 - 18:30 CEST / 10:30 am – 12:30pm ET
  • Session: Poster Session 1, Room 1
  • Abstract/Poster Number: P295
  • Lead Author: Sibyl Wray, MD Hope Neurology, Knoxville, TN

Poster Presentation Title: 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

  • Presentation Date/Time: Wednesday, October 26, 2022 / 16:30 - 18:30 CEST / 10:30 am – 12:30pm ET
  • Session: Poster Session 1, Room 1
  • Abstract/Poster Number: P290
  • Lead Author: Bruce A. C. Cree, MD, PhD, MAS, UCSF Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA

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

  • Presentation Date/Time: Thursday, October 27, 2022 / 17:00 - 19:00 CEST / 11:00am – 1:00pm ET
  • Session: Poster Session 2, Room 1
  • Abstract/Poster Number: P684
  • Lead Author: Enrique Alvarez, MD, University of Colorado, Aurora, CO
  • ePoster Tour Presentation: Friday, Oct. 28 @ 13:35 – 13:40 CEST / 7:35am – 7:40am ET

Poster Presentation Title: 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

  • Presentation Date/Time: Thursday, October 27, 2022 / 17:00 - 19:00 CEST / 11:00am – 1:00pm ET
  • Session: Poster Session 2, Room 1
  • Abstract/Poster Number: P688
  • Lead Author: Lawrence Steinman, MD Stanford University, Stanford, CA, USA

Poster Presentation Title: 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

  • Presentation Date/Time: Thursday, October 27, 2022 / 17:00 - 19:00 CEST / 11:00am – 1:00pm ET
  • Session: Poster Session 2, Room 1
  • Abstract/Poster Number: P700
  • Lead Author: Edward J. Fox, MD, PhD, Central Texas Neurology Consultants, Round Rock, TX

Following the presentations, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfmABOUT 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