TG Therapeutics, Inc. (NASDAQ:TGTX) recently announced the results of its Phase 2 multicenter trial of ublituximab (TG-1101). Ublituximab is the novel glycoengineered anti-CD20 monoclonal antibody in Multiple Sclerosis (RMS)’s relapsing forms. The company presented the data during the Poster Session 1 at the 3rd Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2018 in the Californian City of San Diego.
The Executive Chairman and Chief Executive Officer of TGTX, Michael S. Weiss said that they are very much pleased with the updated Phase 2 data presented at the Forum which included 5 cohorts totaling 40 patients. According to Weiss, what was more exciting was that through the treatment of six months the data remained consistent with more patients as compared to the results presented previously at the 2017 ECTRIMS-ACTRIMS meeting.
Data Demonstrates Positive Effects
The data demonstrated the ublituximab’s positive effect with sustained B-cell depletion through Week 24, 97.5% of subjects without a relapse at Week 24, and complete elimination of T1Gd-enhancing lesions. In his statement, Weiss further added that the 1-hour infusion showed full tolerance representing a more convenient alternative to the anti-CD20 monoclonal antibody that is currently being marketed.
The CEO of TGTX said that the company is looking forward to presenting additional updated Phase 2 data which will include data from all the 48 patients who are enrolled in the Phase 2 study through 52 weeks while the company continues to enroll new patients into its global Phase 3 ULTIMATE trials. The Phase 2 trial evaluates the efficacy and safety of ublituximab at accelerated infusion times in one hour and is a 52-week, placebo controlled, randomized, multi-center study.
The poster presented at the San Diego meeting includes data of six months from the first 40 patients with RMS and treated across five dosing cohorts with ublituximab. The biopharmaceutical company has focused all its attention on ublituximab which is a glycoengineered monoclonal antibody targeting a unique and specific epitope on the antigen called CD20 found mostly on mature B-lymphocytes.