TG Therapeutics to Present Results from the ULTIMATE I & II Phase 3 Trials Evaluating Ublituximab in Multiple Sclerosis at the Upcoming American Academy of Neurology 73rd Annual Meeting

NEW YORK, March 04, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that results of the ULTIMATE I & II Phase 3 trials evaluating ublituximab, the Company’s novel, glycoengineered anti-CD20 monoclonal antibody, in relapsing forms of multiple sclerosis (RMS) have been selected for presentation at the upcoming American Academy of Neurology (AAN) annual meeting, being held virtually April 17 – 22, 2021. The abstract is available online and can be accessed via the below link or on the AAN meeting website at www.aan.com.

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, “We are highly encouraged by the positive topline results from the ULTIMATE I & II Phase 3 trials announced this past December, showing both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period. Importantly, ublituximab treatment resulted in an ARR of less than 0.10 in each of the studies.” Mr. Weiss continued, “We look forward to presenting additional data from the ULTIMATE I & II Phase 3 trials during the AAN conference including safety and secondary endpoint analyses and to working towards a BLA submission targeted around mid-year 2021.”

Presentation Details

Title: Efficacy and safety of ublituximab versus teriflunomide in relapsing multiple sclerosis: Results of the Phase 3 ULTIMATE I and II trials

• Date & Time: Available for viewing beginning Saturday April 17, 2021 at 8:00 AM ET
• Abstract Number: 4494
• Lead Author: Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University
  

ABOUT THE ULTIMATE I & II TRIALS
ULTIMATE 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). In December 2020, we announced that both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period (p<0.005 in each trial). Ublituximab treatment resulted in an ARR of <0.10 in each of ULTIMATE I & II, with a relative reduction in ARR of approximately 60% and 50%, respectively, over teriflunomide. Data from these studies are intended to support a Biologics License Application (BLA) submission for ublituximab in RMS targeted in mid-year 2021. Additional information on these clinical trials can be found at www.clinicaltrials.gov (NCT03277261; NCT03277248).