TG Therapeutics is recruiting participants for two Phase 3 clinical trials that will evaluate the safety and effectiveness of TG-1101 (ublituximab) as a treatment for relapsing forms of multiple sclerosis.
ULTIMATE 1 (NCT03277261) and ULTIMATE 2 (NCT03277248) will compare TG-1101, a glycoengineered monoclonal antibody, with Genzyme’s Aubagio (teriflunomide) in relapsing MS patients. Relapsing MS is a term that covers both relapsing/remitting MS (RRMS) and secondary progressive MS (SPMS) with relapses.
An autoimmune disease like MS occurs when the immune system, which is supposed to defend the body against disease, attacks healthy cells instead. Several autoimmune diseases are linked to abnormalities in immune B-cells, including uncontrolled B-cell multiplication, or proliferation.
TG-1101 targets B-cells, immune cells that express a protein called CD20 on their surface, giving the drug an immunosuppressive function. It is designed to reduce immune system attacks on the protective myelin sheath around neurons, the main trigger of the disease.
“We believe B-cell targeted therapy has the potential to become the leading treatment option for MS and that TG-1101 has the potential to differentiate itself amongst the other B-cell-targeted therapies by offering a rapid, convenient one-hour infusion at an attractive price.” Michael S. Weiss, chief executive officer of TG Therapeutics, said in a press release.
“We are highly encouraged by the early data seen in our Phase 2 trial and look forward to presenting additional data from that study at the ECTRIMS-ACTRIMS meeting next month,” Weiss added. The meeting of the two MS research organizations will be in Paris, Oct. 25-28. ECTRIMS stands for the European Committee for Treatment and Research in Multiple Sclerosis, and ACTRIMS for the Americas Committee for Treatment and Research in Multiple Sclerosis.
The primary objective of both ULTIMATE trials is to see whether TG-1101 can reduce MS patients’ annual relapse rate after 96 weeks of treatment. Each trial will enroll about 440 subjects.
“The approval of Ocrelizumab as a B-cell-targeted therapy for the treatment of MS has truly changed the treatment landscape by offering a new method to treat this disease,” said Dr. Lawrence Steinman of Stanford University, the global chair for both ULTIMATE trials.
“We are excited to lead this Phase 3 trial and evaluate the unique attributes of ublituximab, which may provide a more convenient and possibly less costly treatment option for our patients,” Steinman said. “At our recently concluded investigator meeting, there was much enthusiasm for this trial and the potential benefits this novel agent may provide our patients.”
The ULTIMATE trials will be conducted under a special protocol assessment agreement with the U.S. Food and Drug Administration. This kind of agreement offers a therapy developer assurance that, in the FDA’s regulatory deliberations, the agency will not object to a trial design when a trial is over.