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TG Therapeutics' multiple sclerosis drug shows efficacy, safety in phase 2 trial

TG Therapeutics Inc. said a midstage trial of ublituximab showed that the medicine was safe and effective in treating multiple sclerosis.

The New York-based biopharmaceutical company evaluated ublituximab, also known as TG-1101, in a phase 2 trial to treat relapsing, or returning forms of multiple sclerosis — a disabling disease of the brain and central nervous system.

The company presented final results from the trial during an oral session at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Berlin.

TG's executive chairman and CEO, Michael Weiss, said the data compares favorably with previously presented data for Roche Holding AG's Ocrevus, or ocrelizumab, the only approved therapy that targets the CD20 molecule for treating multiple sclerosis.

After 48 weeks of treatment, 93% of patients had an annual relapse rate of 0.07, while depletion of B cells, which is considered to play an important part in multiple sclerosis treatment, was more than 99%.

About 17% of patients also showed an improvement in their disability. The company added that the medicine was well tolerated across all patients, including those receiving the one-hour, 450-milligram dose infusion in a separate phase 3 program.

TG is carrying out two phase 3 trials of ublituximab called Ultimate I and Ultimate II for treating relapsing forms of multiple sclerosis under a special protocol assessment agreement with the U.S. Food and Drug Administration.