TG Therapeutics presents ublituximab data at ECTRIMS Congress
TG Therapeutics presented the first look at the ULTIMATE I & II Phase 3 trial design and demographic data and updated Phase 2 extension trial data for ublituximab, the Company's novel, glycoengineered anti-CD20 monoclonal antibody, in relapsing forms of multiple sclerosis at the 35th Annual Congress of the European Committee for Treatment and Research in Multiple Sclerosis. The following summarizes the highlights from each presentation during the 35th ECTRIMS meeting: Title: Study Design and Patient Demographics of the ULTIMATE Phase III Trials Evaluating Ublituximab, a Novel Glycoengineered Anti-CD20 Monoclonal Antibody, in Patients with Relapsing Multiple Sclerosis. This presentation includes the study design and demographic data from ULTIMATE I & II, two identical, randomized, international, multi-center, double-blinded, double dummy, active controlled Phase 3 trials, evaluating a twice per year one-hour 450mg infusion of ublituximab in RMS. These trials are being conducted under Special Protocol Assessment agreement with the U.S. Food and Drug Administration and are being led by Lawrence Steinman, MD, of Stanford University. Presentation Highlights: Patient recruitment for ULTIMATE I & II was successfully completed in the second half of 2018. Baseline characteristics of patients enrolled in ULTIMATE I & II are consistent with a typical RMS population. The ULTIMATE I & II trials are expected to elucidate the therapeutic potential of a one hour, 450mg infusion of ublituximab in patients with RMS. Topline results are expected in the second half of 2020. Title: Long-term Follow-up Results from the Phase 2 Multicenter Study of Ublituximab, a Novel Glycoengineered Anti-CD20 Monoclonal Antibody, in Patients with Relapsing Multiple Sclerosis. This presentation includes long-term follow-up data for 45 patients from the Phase 2 trial that enrolled into the Open Label Extension trial and recaps the final efficacy data on patients enrolled in the Phase 2 study through 48 weeks of treatment. Presentation Highlights: Ublituximab continues to be well tolerated, with a median duration of follow-up of 124.7 weeks. No subjects discontinued due to an Adverse Event related to ublituximab on the Phase 2 or during the OLE. AEs deemed at least possibly related to ublituximab were infrequent during the OLE with all patients dosed at 450mg of ublituximab administered in a one-hour infusion. Infusion Related Reactions were rare during the OLE, occurring in only 5 patients, all Grade 1 or 2. An Annualized Relapse Rate of 0.07 was observed with 93% of subjects relapse free at Week 48.