TG Therapeutics announces long-term follow-up data from ublituximab trial
TG Therapeutics announced the presentation of long-term follow-up data from the Phase 2 and open label extension, or OLE, trial of ublituximab, the company's novel glycoengineered anti-CD20 monoclonal antibody, in relapsing forms of Multiple Sclerosis, or RMS. The data are being presented at the American Academy of Neurology. Ublituximab continues to be well tolerated, with a median duration of follow-up of 97.5 weeks. No subjects discontinued due to an adverse event, or AE, related to ublituximab on the Phase 2 or during the OLE. AEs deemed at least possibly related to ublituximab were infrequent during the OLE with all patients dosed 450mg of ublituximab administered in a one-hour infusion. Infusion related reactions, or IRRs, were rare during the OLE, occurring in only 4 patients, all Grade 1 or 2. These long-term safety data, and the Phase 2 efficacy data support the ongoing, fully enrolled, international Phase 3 program evaluating ublituximab for the treatment of RMS. The Phase 3 trials, entitled ULTIMATE I and ULTIMATE II, are being conducted under special protocol assessment, or SPA, agreement with the FDA.