October 1, 2021 News by Steve Bryson, PhD Ublituximab, Potential Relapsing MS Therapy, Up for FDA Approval TG TherapeuticsĀ has applied to the U.S. Food and Drug Administration (FDA) for approval ofĀ ublituximab, the companyās investigational anti-CD20 monoclonal antibody therapy for relapsing forms of multiple sclerosis (RMS). Its application was based on data from the ULTIMATE 1 (NCT03277261) and ULTIMATE 2 (NCT03277248) Phase…
June 30, 2021 News by Marisa Wexler, MS Ublituximab Quite ‘Reassuring’ as Potential MS Therapy, Experts Say In clinical trials, the investigational anti-CD20 therapy ublituximab was the first to push the annualized relapse rate (ARR) below the 0.1 threshold among patients with relapsing forms of multiple sclerosis (MS), while improving disability outcomes in a significant proportion of patients. “The [relapse] rate was below a tenth…
December 14, 2020 News by Marta Figueiredo, PhD Ublituximab Superior to Aubagio at Lowering Relapse Rates, Phase 3 Data Show Ublituximab, an investigational anti-CD20 antibody, outperformed Aubagio (teriflunomide) in lowering the frequency of relapses among people with active, relapsing forms of multiple sclerosis (MS), according to top-line data from the Phase 3 ULTIMATE trials. Full results, including data on safety and secondary goals, are expected to be presented…
May 4, 2020 News by Marisa Wexler, MS Ublituximab Phase 2 Data Support Safety, Efficacy in Relapsing MS The investigational anti-CD20 antibody ublituximabĀ effectively depletes B-cells in people with relapsing forms of multiple sclerosis (MS), reducing the appearance of brain lesions and the risk of relapses, a study into clinical trial results suggests. Findings further suggest that the…
September 18, 2019 News by Patricia Inacio, PhD #ECTRIMS2019 – Data Shows Ublituximab’s Long-term Safety in Relapsing MS, TG Therapeutics Announced Ublituximab continues to be safe and well-tolerated by people with relapsing forms of multiple sclerosis (MS) after a median follow-up of 124.7 weeks ā more than 2 years ā according to data from an extension Phase 2 trial. The data were shown in a…
September 28, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Ublituximab Markedly Reduces Lesions, Promotes B-cell Depletion, Halts Disability Progression in Phase 2 Trial A 48-week treatment of relapsing multiple sclerosis (MS) with TG Therapeuticsā investigational compound ublituximab led to a marked reduction of brain and spinal cord lesions, massive depletion of relapse-associated immune B-cells, and significantly halted disability progression, according to results from a Phase 2 clinical trial. The data…
August 10, 2018 News by Iqra Mumal, MSc TG Therapeutics Reaches Target Enrollment in Phase 3 Trials to Test Ublituximab in Relapsing MS TG Therapeutics announced it has reached target enrollment in the ULTIMATE I and II Phase 3 clinical trials assessing the use of ublituximab (TG-1101) to treat relapsing forms of multiple sclerosis (MS). Ublituximab is a modified anti-CD20 monoclonal antibody, which is designed to target a protein present onĀ mature…
September 19, 2017 News by Patricia Silva, PhD TG Therapeutics Recruiting Patients for Two Phase 3 Trials of Relapsing MS Therapy TG-1101 TG TherapeuticsĀ is recruiting participants for two Phase 3 clinical trials that will evaluate the safety and effectiveness of TG-1101 (ublituximab)Ā as a treatment for relapsing forms of multiple sclerosis. ULTIMATE 1 (NCT03277261) and ULTIMATE 2 (NCT03277248) will compare TG-1101, aĀ glycoengineered monoclonal antibody, with Genzyme’sĀ Aubagio…