TG Therapeutics, FDA Agree on Phase 3 Program to Evaluate Relapsing MS Therapy TG-1101

TG Therapeutics, FDA Agree on Phase 3 Program to Evaluate Relapsing MS Therapy TG-1101

TG Therapeutics and the U.S. Food and Drug Administration (FDA) have agreed on a special protocol assessment for a Phase 3 trial program evaluating TG-1101 (ublituximab) to potentially treat relapsing forms of multiple sclerosis (MS).

A special protocol assessment (SPA) is a procedure by which the agency officially evaluates the design and size of proposed protocols meant to ground a new drug application (NDA). The SPA marks the conditions under which the trial design adequately addresses objectives that, if met, will support consequent regulatory submission for approval of TG-1101.

Stanford University’s Dr. Lawrence Steinman will lead the program, which is expected to begin this year. It includes two Phase 3 clinical trials (ULTIMATE I and ULTIMATE II) — both randomized, double-blind, active-controlled studies comparing TG-1101 to Aubagio (teriflunomide) in patients with relapsing MS.

By targeting relapsing MS, TG-1101 could potentially be approved to two particular forms of the disease: relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS), which often follows RRMS.

TG-1101 is TG’s novel glyco-engineered monoclonal antibody that targets a specific and unique epitope on the CD20 protein found on mature B-cells. The primary endpoint of the trials will be changes in annualized relapse rate after 96 weeks of treatment in about 440 randomized patients in each trial.

“B-cell targeted therapy with anti-CD20 monoclonal antibodies has been shown to be very active in the treatment of multiple sclerosis, and with the recent approval of ocrelizumab, we have entered a new era of B-cell targeted therapy for MS,” Steinman said in a press release.

Ocrevus (ocrelizumab) is a humanized monoclonal antibody that targets B-cells with the CD20 molecule. The FDA approved it on March 28, 2017, as an MS treatment.

“The Phase 2 data recently presented for ublituximab demonstrates an encouraging safety and efficacy profile in the treatment of MS with this novel glyco-engineered anti-CD20 monoclonal antibody,” said Steinman. “We believe the unique attributes of ublituximab — in particular the rapid infusion times and potential pricing advantages — may provide added convenience and enhance patient care and access over currently available therapies.”

Michael S. Weiss, TG’s executive chairman and CEO, said the New York-based pharma company hopes this Phase 3 program “will establish TG-1101 as an important new drug” in the treatment of MS.

“The early data from our Phase 2 clinical trial, the highly successful pivotal results for the anti-CD20 monoclonal antibody ocrelizumab in MS, and the substantial safety data generated in our oncology program, gives us a high level of confidence in the potential for a successful outcome,” he said. “We look forward to enrolling our first patient before the end of the summer.”

Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

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