TG Therapeutics (NASDAQ:TGTX) reported positive topline data from its two Phase 3 trials evaluating ublituximab, an anti-CD20 monoclonal antibody, for the treatment of relapsing forms of multiple sclerosis (MS).
Patients in the ULTIMATE I and ULTIMATE II studies received either a one-hour 450 mg infusion of ublituximab every six months or 14 mg of once-daily oral teriflunomide. Both studies met their primary endpoint, with ublituximab treatment resulting in an annual relapse rate of less than 0.10.
In addition, patients in the ULTIMATE I and ULTIMATE II studies who received ublituximab demonstrated a relative reduction in annual relapse rate of 60% and 50%, respectively, compared with teriflunomide.
“If approved, ublituximab has the potential to offer patients a one-hour infusion, which we believe will be an attractive option for many patients with MS,” Michael Weiss, TG Therapeutics’ executive chairman and CEO, said in a statement.
“We look forward to a detailed presentation of the data at a major medical meeting in the first half of 2021 once the full data are analyzed, as well as completing a BLA submission targeted for mid-next year,” he added.
