US-based biopharmaceutical firm TG Therapeutics has commenced enrolment for the Phase III ULTIMATE clinical programme of TG-1101 (ublituximab) to treat patients with relapsing multiple sclerosis (RMS).
TG-1101 is a glycoengineered monoclonal antibody being developed to target a specific epitope on the CD20 antigen present on mature B-lymphocytes.
The programme comprises global, randomised, multi-centre, double-blinded, double-dummy, active-controlled ULTIMATE I and ULTIMATE II trials that will compare the safety and efficacy of TG-1101 with teriflunomide.
TG Therapeutics executive chairman and CEO Michael Weiss said: "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.
“We are highly encouraged by the early data seen in our Phase II trial and look forward to presenting additional data from that study at the ECTRIMS-ACTRIMS meeting next month."
The programme will be led by Stanford University professor Dr Lawrence Steinman, and enrol a total of 880 subjects, with 440 in each trial.
Dr Steinman said: “We are excited to lead this Phase III trial and evaluate the unique attributes of ublituximab, which may provide a more convenient and possibly less costly treatment option for our patients.”
The primary endpoint for both trials is annualised relapse rate (ARR) after 96 weeks of treatment.
Image: Photomicrograph of a demyelinating MS-lesion. Photo: courtesy of Marvin 101.