Lapix Therapeutics Inc. has announced the successful outcome of its pre-IND meeting request with the FDA to achieve alignment on the company's IND-enabling plan for LPX-TI641, being developed for neuro-autoimmune indications such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), and myelin oligodendrocyte glycoprotein antibody disease (MOGAD).

Despite pipeline setbacks in 2022, TG Therapeutics Inc. ended the year on a positive note, with U.S. FDA approval of its glycoengineered CD20 monoclonal antibody, ublituximab, in relapsing multiple sclerosis (MS). Branded Briumvi, the drug is set to go up against approved anti-CD20 antibodies Kesimpta (ofatumumab, Novartis AG) and Ocrevus (ocrelizumab, Roche Holding AG).

2021 was the year Aduhelm (aducanumab, Biogen Inc.) was approved as the first amyloid-β-busting drug for Alzheimer’s disease. And in 2022, there was as much need for an effective AD drug as ever. Aduhelm’s commercial fate was sealed with the decision of the Center for Medicare & Medicaid Services (CMS) that the drug would only be reimbursed in clinical trials approved by the CMS or the NIH.

Abata Therapeutics Inc. has selected its first development candidate, ABA-101, an autologous regulatory T cell (Treg) therapy for the treatment of progressive multiple sclerosis (MS). ABA-101 targets MS patients with nonrelapsing progressive disease who have a DRB1*15:01 genetic haplotype and for whom imaging evidence of ongoing inflammatory tissue injury has been observed.

With labeling discussions begun for TG Therapeutics Inc.’s ublituximab to treat relapsing multiple sclerosis, Wall Street was optimistic about the PDUFA date of Dec. 28 assigned to the glycoengineered CD20 monoclonal antibody. Shares of New York-based TG (NASDAQ:TGTX) closed Nov. 11 at $9.34, up 91 cents, or 10.8%, having risen more than 52% over the previous five days. With late-cycle review talks with the U.S. FDA done, ublituximab seemed well on its way.

Researchers from Washington University presented data from a study that aimed to identify myeloid-derived suppressor cell (MDSC) markers in patients with multiple sclerosis (MS).

G protein-coupled receptor 183 (GPR183/EBI2) is one of the key regulators of the innate immune system, and it has been shown to be upregulated in multiple sclerosis (MS) plaques. In a recently reported study, researchers from Medical University of Gdansk evaluated the effects of pharmacological modulation of GPR183 signaling on remyelination.

Dimethylfumarate (DMF) is largely used for treating multiple sclerosis (MS), but about 61% of DMF-treated patients develop lymphopenia, with its consequent associated risks. Biomarkers for monitoring treatment efficacy with DMF in patients with MS would be helpful in this field.