- June 20, 2018
- Posted by: PharmaScroll
- Category:
TG Therapeutics announced updated results from the Phase 2 multicenter trial of ublituximab (TG-1101), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in relapsing forms of Multiple Sclerosis (RMS). The data was presented today at the 4thCongress of the European Academy of Neurology in Lisbon, Portugal, via an oral session titled “MS and related Disorders 2”.
Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, “We are extremely pleased to see that the preliminary Week 48 data presented today from this Phase 2 trial supports the Week 24 data presented earlier this year at the AAN meeting. While only an early look at the Week 48 timepoint, the data continue to be impressive and suggestive of a highly efficacious anti-CD20 monoclonal antibody with a manageable safety profile that can be administered in a convenient one-hour infusion. Mr. Weiss continued, “We look forward to presenting the final results from this Phase 2 trial including Week 48 data on up to 48 patients at a major medical meeting later this year.”
Oral Presentation Title:Phase 2 Multicenter Study Results of Ublituximab, a Novel Glycoengineered AntiCD20 Monoclonal Antibody (mAb), in Patients with Relapsing Multiple Sclerosis (RMS)
This Phase 2 trial is a 48-week randomized, placebo controlled, multi-center study evaluating the safety and efficacy of ublituximab at accelerated infusion times as fast as one hour. Today’s oral presentation includes Week 24 data from 48 patients with relapsing forms of multiple sclerosis (RMS) that were treated with ublituximab across six dosing cohorts, as well as data from the first 14 patients through Week 48.
Highlights:
- An Annualized Relapse Rate (ARR) of 0.07, calculated cumulatively, based on 48 subjects with a mean follow-up of approximately 11 months
- 99% median B-cell depletion was observed at week 4 and maintained at Week 24 (n=44)
- Ublituximab completely eliminated all (100%) of T1 Gd-enhancing lesions at Week 24 (n=44) (p=0.003) and at Week 48 (n=14)
- 67% Reduction in T2 lesion volume at Week 24 from baseline (n=44) and a 10.5% reduction in T2 lesion volume at Week 48 from baseline (n=14)
- Ublituximab was well tolerated across all patients including those receiving rapid infusions, as low as a one hour for the 450mg Phase 3 dose
These data presentations support the international Phase 3 ULTIMATE program evaluating ublituximab for the treatment of relapsing forms of Multiple Sclerosis (RMS). The Phase 3 trials, entitled ULTIMATE I and ULTIMATE II, are being conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) and are being led by Lawrence Steinman, MD, of Stanford University. The ULTIMATE trials are currently enrolling and complete enrollment is expected by the end of 2018.
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News Source: TG Therapeutics Website
Image Source: https://www.neurologyadvisor.com/cmsc-2018/multiple-sclerosis-treatment-ublituximab-reduces-gd-lesions/article/769959/