TG Therapeutics is recruiting participants for two Phase 3 clinical trials that will evaluate the safety and effectiveness of TG-1101 (ublituximab) as a treatment for relapsing forms of multiple sclerosis. ULTIMATE 1 (NCT03277261) and ULTIMATE 2 (NCT03277248) will compare TG-1101, a glycoengineered monoclonal antibody, with Genzyme’s Aubagio…

TG Therapeutics will discuss ublituximab's ability to deplete B-cells linked to multiple sclerosis and to reduce inflammatory brain lesions at the 7th Joint ECTRIMS–ACTRIMS Meeting in Paris next month. The three presentations will cover preliminary results of a Phase 2 clinical trial of ublituximab's safety and effectiveness as a treatment for relapsing forms of MS, the company said in a press release. The conference will be Oct. 25-28. Dr. Amy E. Lovett-Racke of Ohio State University will discuss ublituximab's ability to decrease B-cells associated with MS after six months of treatment. Ublituximab is an antibody that targets B-cells carrying the CD20 protein on their cell surfaces. These cells are thought to play a role in MS development. Dr. Matilde Inglese of the Icahn School of Medicine at Mount Sinai in New York will discuss ublituximab's ability to decrease study participants' inflammatory brain lesions. And Dr. Edward Fox of Central Texas Neurology Consultants, the trial's principal investigator, will do a poster-session presentation on the study's patient characteristics and preliminary results as a whole, including safety. The ongoing Phase 2 trial is still recruiting patients with relapsing forms of MS. Researchers are randomly assigning participants to receive intravenous infusions of either ublituximab or a placebo. One of the study’s primary goals is to see how well ublituximab depletes B-cells 28 days after the start of treatment. Another primary goal is to see how safe the therapy is, with the measurement being treatment-related adverse events that patients experience over six months. Ublituximab’s ability to reduce relapses will be a secondary measure of the trial. Researchers will assess it after 48 weeks of treatment. Fox, who is the director of the Multiple Sclerosis Clinic of Central Texas, and a clinical assistant professor at the University of Texas Medical Branch in Round Rock, made a ublituximab presentation at the 3rd Congress of the European Academy of Neurology in June. It revealed that the therapy nearly depleted B-cells only four weeks after treatment started. Earlier data suggests that ublituximab can be administered in only one hour. Ocrevus, the only approved MS therapy that targets B-cells with CD20, requires 3 1/2 hours. Although the Phase 2 trial is continuing, the data generated so far supports plans for two Phase 3 trials, TG Therapeutics said. They will randomize patients to receive either ublituximab or Aubagio. The trials, which the company hopes to start by the end of September, will be conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration. It allows the FDA to evaluate the design and population size of a trial a company intends to use to seek a drug's regulatory approval. The FDA has refused to approve therapies whose trial design it believed to be flawed. Obtaining a design sign-off before a trial improves the chance of a treatment being approved if it meets the study's objectives.

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…

TG Therapeutics’ investigational treatment — ublituximab (TG-1101) — led to a near total depletion of B-cells in patients with relapsing forms of multiple sclerosis (MS) taking part in an ongoing Phase 2 trial, the company recently announced. In addition, the company said that ublituximab had an infusion time as short as one hour, without excessive side…

Early data from TG Therapeutics’ Phase 2 trial of its B-cell-targeting experimental multiple sclerosis (MS) treatment ublituximab (TG-1101), showed that the drug is well-tolerated and effectively reduces B-cells in the blood. MS therapies that deplete B-cells have been effective in relapsing and progressive forms of MS. Like other B-cell-targeting drugs in…

The U.S. Food and Drug Administration (FDA) has designated TG-1101 (ublituximab), a glycoengineered anti-CD20 monoclonal antibody by TG Therapeutics, an orphan drug to advance its development. The drug is a potential treatment for neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD), two relapsing-remitting autoimmune diseases with similarities to multiple sclerosis. Currently, there are…

TG Therapeutics recently announced the opening of a new clinical trial evaluating TG-1101, its glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing-remitting multiple sclerosis (RRMS). The Phase 2 clinical trial, titled “A Placebo-Controlled Multi-Center Phase 2 Dose Finding Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients…