TG Therapeutics’ ublituximab (TG-1101) nearly eradicated a type of immune B-cell believed to be involved in multiple sclerosis, according to a Phase 2 clinical trial.
The result was that none of the patients had a relapse during the first six months of the trial (NCT02738775), which is continuing, researchers said.
In addition, ublituximab reduced the brain and spinal cord lesions of the relapsing MS patients involved in the trial and prevented new ones from forming.
The company will present the interim trial results in three poster presentations at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, Oct. 25-28.
Meanwhile, researchers will continue to study the effectiveness of ublituximab, a B-cell-depleting antibody, versus a placebo, for another six months. The trial is being held at several U.S. medical facilities.
Participants receive two initial infusions of ublituximab or a placebo on day 1 and 15 during the first 28 days. After this initial period, those in the placebo-group are also given ublituximab and followed for 52 weeks.
A key trial finding was that over the initial 24 weeks of the trial, the treatment nearly wiped out a type of B-cell known as CD20 that scientists believe is involved in the development of MS. Only 1 percent of the B-cells remained after a month.
While helpful immune T-cell numbers dropped slightly after the first ublituximab infusion, they bounced back quickly.
Researchers also reported a reduction in patients’ magnetic resonance imaging (MRI) lesions, with no new inflammatory lesions appearing during the six months.
So far, none of the trial participants has had a serious adverse event. Most of the adverse events were mild or moderate and related to the infusions.
The trial also demonstrated that speeding up infusions did not increase infusion-related reactions. The speed-up results indicated that — if proven effective and safe — ublituximab will be more convenient for patients than B-cell-depleting drugs that require infusions stretching over several hours.
“We are excited to release the first clinical MRI data of TG-1101 in patients with RMS [relapsing MS], as we believe the abstract data presents an extremely compelling case for the use of TG-1101 in the treatment of patients with MS,” Michael S. Weiss, TG Therapeutics’ executive chairman and CEO, said in a press release.
“We will continue to update these data at multiple conferences over the next year as we treat and follow the 48 patients” in six groups for up to a year, Weiss added.