TG Therapeutics is working to develop a subcutaneous, or under-the-skin, version of Briumvi (ublituximab-xiiy), its approved therapy for relapsing forms of multiple sclerosis (MS). The company said it plans to start a pivotal clinical program this year which could support an application seeking approval of the…

TG Therapeutics has secured three additional U.S. patents for Briumvi (ublituximab-xiiy), an anti-CD20 antibody that’s been approved to treat relapsing forms of multiple sclerosis (MS). Issued by the U.S. Patent and Trademark Office, the patent numbers 11,807,689; 11,814,439; and 11,884,740 specifically cover the composition and…

Briumvi (ublituximab-xiiy) recently became the third anti-CD20 monoclonal antibody to be approved by the U.S. Food and Drug Administration (FDA) as a treatment for relapsing forms of multiple sclerosis (MS). TG Therapeutics, the therapy’s developer, is now aiming to make Briumvi the most accessible therapy in its…

TG Therapeutics’ Briumvi (ublituximab-xiiy), a CD20 inhibitor recently approved for adults with relapsing forms of multiple sclerosis (MS), is now commercially available in the U.S., the company announced. The treatment was approved in the U.S. late last year, with indications that include clinically isolated syndrome, relapsing-remitting MS (RRMS),…

Treatment with the experimental B-cell depleting therapy ublituximab significantly outperformed Aubagio (teriflunomide) at reducing relapse rates and the number of lesions in people with relapsing forms of multiple sclerosis (MS), according to updated data from the Phase 3 ULTIMATE clinical trials. The two medications had comparable effects…

Ublituximab, an investigational antibody-based treatment for multiple sclerosis (MS), was efficacious across most patient subgroups, and led to marked improvements in disability and quality of life over nearly two years. This is according to new exploratory analyses from the identical Phase 3 ULTIMATE I and II trials, which evaluated…

FDA Decision on Ublituximab for Relapsing MS Pushed to Year’s End Ublituximab is similar to Ocrevus (ocrelizumab) and Kesimpta (ofatumumab), which also target B-cells, the immune cells that play a role in the inflammatory attacks that harm the central nervous system of people with MS. Each of…

The U.S. Food and Drug Administration (FDA) is extending by three months its review of ublituximab, an experimental anti-CD20 antibody being developed by TG Therapeutics for relapsing forms of multiple sclerosis (MS). The FDA had agreed to review the company’s application requesting ublituximab’s approval late last year, and…

More relapsing multiple sclerosis (MS) patients given ublituximab remained relapse-free over the two-year long Phase 3 ULTIMATE clinical trials, compared to those given Aubagio (teriflunomide), new data show. “The prevention of relapses represents an important goal of disease-modifying therapy with the potential for a marked impact on the accumulation of disability,” Lawrence Steinman,…

Ublituximab, an experimental therapy for relapsing multiple sclerosis (MS) patients, outperformed Aubagio on a number of disability-related outcomes in the ULTIMATE clinical trials, new data show. The findings were presented in a series of posters at the 2022 American Academy of Neurology (AAN) Annual Meeting, being held in…

#ACTRIMS2022 – Cognitive Training Paired With tDCS Aids Patients A treatment to clear “cog fog” would be welcomed by many people with MS. Over 75% of us are troubled by cognitive problems. In this study, adding painless transcranial direct current stimulation to standard cognitive training improved results when compared…

The experimental medication ublituximab significantly reduces the number of new brain lesions with severe nerve cell degeneration in people with relapsing multiple sclerosis (MS) as compared with Aubagio (teriflunomide), according to new data from the Phase 3 ULTIMATE clinical trials. The findings showed that ublituximab induces a rapid…

The U.S. Food and Drug Administration (FDA) has agreed to review TG Therapeutics’ application seeking the approval of ublituximab as a treatment for people with relapsing forms of multiple sclerosis. An FDA’s decision is expected on or before Sept. 28. The agency is not currently planning to hold an…

TG Therapeutics  has applied to the U.S. Food and Drug Administration (FDA) for approval of ublituximab, the company’s investigational anti-CD20 monoclonal antibody therapy for relapsing forms of multiple sclerosis (RMS). Its application was based on data from the ULTIMATE 1 (NCT03277261) and ULTIMATE 2 (NCT03277248) Phase…

In clinical trials, the investigational anti-CD20 therapy ublituximab was the first to push the annualized relapse rate (ARR) below the 0.1 threshold among patients with relapsing forms of multiple sclerosis (MS), while improving disability outcomes in a significant proportion of patients. “The [relapse] rate was below a tenth…

TG Therapeutics has expanded its contract with Samsung Biologics to manufacture ublituximab, an investigational therapy for relapsing forms of multiple sclerosis (MS). “Samsung is the global leader in biologics manufacturing and we are happy to have them as our partner as we look forward to the potential commercialization…

Editor’s note: The Multiple Sclerosis News Today team is providing in-depth coverage of the 2021 Virtual AAN Annual Meeting, April 17–22. Go here to read the latest stories from the conference. Ublituximab, an investigational therapy for relapsing forms of multiple sclerosis (MS), significantly outperformed Aubagio (teriflunomide) at reducing patients’…

Ublituximab, an investigational anti-CD20 antibody, outperformed Aubagio (teriflunomide) in lowering the frequency of relapses among people with active, relapsing forms of multiple sclerosis (MS), according to top-line data from the Phase 3 ULTIMATE trials. Full results, including data on safety and secondary goals, are expected to be presented…

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…

Ublituximab continues to be safe and well-tolerated by people with relapsing forms of multiple sclerosis (MS) after a median follow-up of 124.7 weeks — more than 2 years — according to data from an extension Phase 2 trial. The data were shown in a…

The loss of immune B-cells, and the resulting changes in the profile of immune T-cells, is a major mechanism of action for the beneficial effects seen with ublituximab treatment in multiple sclerosis (MS) patients, a study suggests. B-cells are a type of immune cell best known for producing…

Treatment with ublituximab continues to be safe and well-tolerated by patients with relapsing forms of multiple sclerosis, according to an extension study of a Phase 2 trial. According to a press release, Edward Fox, MD, PhD, from Central Texas Neurology Consultants, will give the presentation on May 7 at poster session P3: MS Clinical Trials and Therapeutic Research. Ublituximab is an investigational monoclonal antibody being developed by TG Therapeutics to target the immune B-cell marker protein CD20. This leads to the depletion of B-cells from the blood and central nervous system — B-cells are activated during MS relapses. According to the company, ublituximab may be superior to current anti-CD20 treatments in MS, enabling both lower doses and shorter infusion times. Final results of the main TG-Therapeutics-sponsored Phase 2 trial were recently presented at the 4th Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, held in Dallas, Texas. Data showed that 93% of the 48 patients enrolled (mean age 40 years) were relapse-free after a 48-week treatment with ublituximab. The annualized relapse rate — the number of relapses per year — was 0.07. In addition, median B-cell depletion was more than 99% throughout 48 weeks. Moreover, 87% of participants showed no evidence of clinical disease. Magnetic resonance imaging showed a complete elimination of T1 lesions at 24 and 48 weeks 24 in all 46 patients analyzed. Mean T2 lesion volume decreased by 10.6% at 48 weeks, compared with the beginning of the study. T1 lesions refer to areas of active inflammation and disease activity, while T2 lesions are a measure of the total amount of lesions, both old and new. Ublituximab was found to be well-tolerated, and did not induce an severe treatment-related adverse events. The most frequent adverse events were infusion-related reactions. No patient had to discontinue treatment due to an ublituximab-related side effect. At the upcoming AAN meeting, Fox will present data on both this Phase 2 trial and its open-label extension, in which 37 patients from the primary study continued receiving one-hour infusions of 450 mg of ublituximab every 24 weeks for an additional 96 weeks. Safety was monitored throughout the study, and disability assessments using the Expanded Disability Status Scale were conducted every 48 weeks. As of October 2018, nearly 30% of participants had completed 48 weeks of treatment in the extension study. Results showed that ublituximab continues to be well-tolerated, with no discontinuations due to adverse events. “The Phase 2 OLE supports that one-hour infusions of [ublituximab] continue to be safe and well tolerated,” the researchers wrote. Of note, five of the eight study authors are affiliated with TG Therapeutics. The team expects additional patient follow-up data from the study to be available by the time of the AAN presentation. According to the scientists, the results support the ongoing Phase 3 ULTIMATE program, which includes the ULTIMATE 1 and ULTIMATE 2 trials. These studies are comparing the efficacy and safety of 450 mg of ublituximab with Aubagio over 96 weeks of treatment in relapsing MS patients. Both trials are led by Lawrence Steinman, MD, at Stanford University. TG Therapeutics expects to have results from these trials as early as mid-2020.

Full results of a Phase 2 clinical trial testing TG Therapeutics’ lead candidate ublituximab (TG-1101) for relapsing multiple sclerosis (MS) showed that treatment for 48 weeks resulted in a marked reduction of brain and spinal cord lesions, an almost complete depletion of relapse-associated immune B-cells, and significantly halted disability…

A 48-week treatment of relapsing multiple sclerosis (MS) with TG Therapeutics’ investigational compound ublituximab led to a marked reduction of brain and spinal cord lesions, massive depletion of relapse-associated immune B-cells, and significantly halted disability progression, according to results from a Phase 2 clinical trial. The data…

TG Therapeutics announced it has reached target enrollment in the ULTIMATE I and II Phase 3 clinical trials assessing the use of ublituximab (TG-1101) to treat relapsing forms of multiple sclerosis (MS). Ublituximab is a modified anti-CD20 monoclonal antibody, which is designed to target a protein present on mature…

New results from a Phase 2 trial evaluating TG Therapeutics’ ublituximab continue to support the therapy’s efficacy in treating relapsing forms of multiple sclerosis (MS). This investigative infusion therapy is now moving into a Phase 3 study. Treatment with 450 mg of ublituximab delivered intravenously in a rapid fashion…

Researchers Identify Testosterone-triggered Molecule That Protects Men From MS This finding is an extension of research that has already indicated that a higher testosterone level reduces the chance of a person developing multiple sclerosis (MS). This new research focuses on a testosterone-related molecule that, these…

TG Therapeutics‘ ublituximab (TG-1101) led to a remarkable reduction in multiple sclerosis patients’ brain and spine lesions, a Phase 2 clinical trial showed. In fact, none of the treated patients had new gadolinium-enhancing lesions — or damaged nerve cell areas — six months after treatment, researchers said. Their analysis covered patients…

TG Therapeutics’ ublituximab 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, 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.

Fast Forward, a non-profit subsidiary of the National Multiple Sclerosis Society, will give financial support to TG Therapeutics to advance TGR-1202 (umbralisib) into preclinical testing as a potential oral therapy for progressive forms of multiple sclerosis. The support, whose value was not specified, is part of a Sponsored Research Agreement between Fast Forward and the company. Research work will be led by Lawrence Steinman, MD, a professor of pediatrics, neurology, and neurological sciences at Stanford University. TGR-1202 is an orally administrated inhibitor that blocks a signaling enzyme called PI3K delta. Immune cells such as B-cells have high levels of this enzyme, which is thought to be important for cell proliferation and survival. "We look forward to evaluating umbralisib [TGR-1202]'s effect on our preclinical progressive MS models in hopes to move umbralisib closer to clinical development in MS," Steinman said. The approval of Ocrevus (ocrelizumab), by Genentech, to treat primary progressive and relapsing multiple sclerosis underscored the potential of B-cell-targeted therapies for MS patients. As a result, investigative drugs that also aim to bolster B-cell survival or activity, such as those being developed by TG Therapeutics, are an attractive approach to potentially treating patients. Another potential treatment by the company — an engineered antibody, TG-1101 — targets a specific sequence on the CD20 protein found on immune B-cells. This infusion therapy is now in two Phase 3 clinical studies for relapsing multiple sclerosis, ULTIMATE I and ULTIMATE II. Both are currently enrolling patients at sites in Kentucky, Tennessee, and New York.