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 on mature B-cells, which are immune cells involved in regulating the autoimmune response and in the development of lesions in the central nervous system (CNS). Ublituximab depletes the number of B-cells.
The ULTIMATE I (NCT03277261) and II (NCT03277248) are global, randomized, multi-center, double-blinded and independent Phase 3 clinical trials investigating the safety and effectiveness of ublituximab in comparison to Aubagio (teriflunomide, marketed by Sanofi), an approved immunomodulatory drug for treating patients with relapsing MS.
Both studies, which are being led by Lawrence Steinman, MD, of Stanford University, are being performed under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).
An SPA is an advanced declaration from the FDA that an unfinished Phase 3 trial’s design, clinical goals, and statistical analyses are acceptable for FDA approval.
Despite achieving its target enrollment of 440 patients, the studies will continue to enroll patients until mid-September in order to provide an opportunity for more patients to participate.
The target enrollment into these Phase 3 trials was accomplished nine months before the team had anticipated, which will now allow TG Therapeutics to determine the outcome of this study as early as mid-2020.
Michael Weiss, executive chairman and CEO of TG Therapeutics, said in a press release: “We’ve presented several early cuts of data from our Phase 2 MS trial of ublituximab at key conferences over the last year and believe the safety and activity demonstrated thus far support our belief that the ULTIMATE Phase 3 studies will be positive.”
At the 2018 CMSC Annual Meeting, TG therapeutics presented data showing that treatment with 50 mg of ublituximab was well-tolerated and led to a massive decrease in immune B-cells. This was associated with reduction in lesions in the brains and spinal cords of patients, and significantly delayed disability progression.
“We look forward to presenting the final data from our Phase 2 MS study at a major medical conference before year end. With the Phase 3 MS studies completing enrollment earlier than expected, we now have multiple pivotal data read-outs projected to occur between now and mid-2020,” Weiss said.