The investigational anti-CD20 antibody ublituximab effectively depletes B-cells in people with relapsing forms of multiple sclerosis (MS), reducing the appearance of brain lesions and the risk of relapses, a study into clinical trial results suggests.
Findings further suggest that the therapy has a good safety profile.
The study, “A phase 2 multicenter study of ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis,” was published in the Multiple Sclerosis Journal. It was funded by TG Therapeutics, the company developing ublituximab.
B-cells, a type of immune cell, help to drive the inflammation that causes nervous system damage in MS. These cells express a molecular marker — a protein ± called CD20, so that antibodies against CD20 can kill B-cells through a variety of molecular mechanisms.
Ublituximab is an anti-CD20 antibody engineered to maximize B-cell death through a process called antibody-dependent cellular cytotoxicity (ADCC). The therapy is being developed as a treatment for MS, as well as B-cell cancers.
The Phase 2 clinical trial (NCT02738775) evaluated the safety and efficacy of ublituximab in 48 people with relapsing MS, which includes relapsing-remitting MS and active secondary progressive MS.
Participants — with an average age of 40, and mean disease duration of 7.7 years; 65% female — were enrolled into six treatment groups, and given three infusions of ublituximab (150 mg over 1–4 hours on day one, and 450 mg to 600 mg over 1–3 hours on day 15 and week 24). People in each successive group received a higher dose and/or at a faster infusion rate than the preceding one.
Two patients in each group were initially given a placebo; after 28 days, they were moved to ublituximab at the respective dose/schedule of their group. In total, 45 participants (94%) received all ublituximab doses and completed the 48-week study.