- April 26, 2018
- Posted by: PharmaScroll
- Category:
TG Therapeutics, Inc. (NASDAQ:TGTX), 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 during Poster Session P3, from 5:30 PM – 7:00 PM PT, April 24th 2018, at the American Academy of Neurology 70th Annual Meeting in Los Angeles, California.
Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, “We are extremely pleased by the data presented which now includes a total of 48 patients across six dosing cohorts for a period of up to 24 weeks. With more patients now through 24 weeks of follow-up, the data continue to confirm the efficacy of ublituximab with sustained B-cell depletion, 100% reduction in T1 Gd-enhancing lesions, and most importantly, an annualized relapse rate (ARR) that remains below the ARR observed with ocrelizumab, the only approved anti-CD20 monoclonal antibody for MS, in its similarly sized Phase 2 study. ARR is the primary endpoint of our Phase 3 trial, which was modeled and powered based on the results from the ocrelizumab pivotal trial. We are excited by the emerging clinical profile of ublituximab that appears to have comparable to better activity than ocrelizumab, with a manageable safety profile and the convenience of a one hour infusion.” Mr. Weiss continued, “We look forward to presenting additional data from this Phase 2 trial including 48 week data on up to 48 patients at major medical meetings later this year.”
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 poster includes 6 month (24 week) data from 48 patients with relapsing forms of multiple sclerosis (RMS) that were treated with ublituximab across six dosing cohorts.
Poster Title: Final MRI Results At 6 Months From A Phase 2 Multicenter Study Of Ublituximab, A Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), In Patients With Relapsing Forms Of Multiple Sclerosis (RMS), Demonstrates Complete Elimination Of Gd-Enhancing Lesions (Abstract # 3253)
Poster Highlights:
- An Annualized Relapse Rate (ARR) of 0.05 was observed at Week 24 (n=48)
- 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)
- 98% of subjects were relapse free at Week 24
- One confirmed relapse was reported, in Cohort 1. The patient was initially randomized to the placebo arm. The relapse occurred shortly (12 days) after crossover to active treatment of 150mg of ublituximab. The patient remains on study and has received the second and third infusions of ublituximab and to date has remained relapse free.
- 83% of subjects showed improved or stable EDSS with a mean EDSS improvement from baseline of 0.29
- 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 in the first quarter of 2019.
POSTER
A copy of the above poster can be found on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtxinc.com/publications.cfm
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News Source: TG Therapeutics Website
Image Source: https://www.cbsnews.com/news/multiple-sclerosis-drug-ocrevus-ocrelizumab-fda-approved/