dosing

Enrollment is complete for the randomized part of ENHANCE, a large clinical trial testing a new dosing schedule for Briumvi (ublituximab-xiiy) in adults with relapsing forms of multiple sclerosis (MS), developer TG Therapeutics announced. This part of the Phase 3b ENHANCE study (NCT05877963) is specifically testing whether…

People with multiple sclerosis (MS) may receive less frequent treatments with anti-CD20 therapies without increasing their risk of disease activity or disability progression. That’s according to a new meta-analysis of published studies that investigated the use of different dosing schedules for anti-CD20 therapies — approved treatments that deplete the…

A multicenter Phase 2a clinical trial testing foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS) has begun dosing patients at Weill Cornell Medicine Multiple Sclerosis Center in New York. The Phase 2a study (NCT06292923) is assessing the safety and efficacy of Tiziana Life Sciences‘ therapy,…

From 2019 to 2023, people with relapsing-remitting multiple sclerosis (RRMS) in France on treatment with Tysabri (natalizumab) adopted more at-home dosing and longer periods between doses, according to a review by researchers of the French national hospital database. An increasing use of the therapy during…

A multicenter Phase 2a clinical trial testing Tiziana Life Sciences’  foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS) has dosed the first patients enrolled at Yale MS Center. The Phase 2a study (NCT06292923) is assessing the treatment’s safety and efficacy against a placebo in…

A first group of healthy adults has been dosed in a Phase 1 safety and tolerability trial of Lucid-21-302, a potential myelin-protective oral treatment for multiple sclerosis (MS), regardless of disease type. These initial volunteers will serve as the trial’s sentinels, an occasional study feature allowing for a…

FSD Pharma has entered an agreement to launch a Phase 1 clinical trial that will test multiple ascending doses of Lucid-21-302 — an oral treatment candidate commonly known as Lucid-MS, for all types of multiple sclerosis (MS) — in healthy volunteers. The company’s subsidiary Huge Biopharma Australia established…

Tiziana Life Sciences has dosed the first patient in a Phase 2a clinical trial testing its foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS). The trial will include about 54 participants, enrolled across six clinical sites. Patients will be randomly assigned to receive one of two…

A personalized dosing schedule for Tysabri (natalizumab) that aims to maintain blood levels of the drug above a certain threshold seems to be just as effective for controlling disease activity in relapsing-remitting multiple sclerosis (RRMS) as the approved every-four-week dosing schedule. That’s according to interim data from an…

People with multiple sclerosis (MS) being treated with Ocrevus (ocrelizumab) less frequently than the recommended every six months are not more likely to experience inflammatory disease activity, an analysis of some 360 patients whose dosing schedules changed during the COVID-19 pandemic suggests. Nicole Bou Rjeily, MD, a postdoctoral…

Patient dosing has begun in a Phase 2 trial testing Denali Therapeutics‘ investigational oral RIPK1 inhibitor SAR443820 in people with multiple sclerosis (MS). The clinical trial (NCT05630547) seeks to enroll about 168 patients, age 18–60, with either relapsing-remitting MS (RRMS), active and nonactive secondary progressive…

Dosing of NVG-291, NervGen Pharma’s investigational therapy for multiple sclerosis (MS) and other nervous system diseases, was completed in the third and final group of healthy postmenopausal women in a Phase 1 clinical trial. “Completing the dosing of the final [group] of postmenopausal females in the MAD [multiple…

Timing doses of rituximab by measuring B-cell counts is a more tailored approach to treatment, and it effectively reduces relapses and disability progression in multiple sclerosis (MS), according to a small study in patients with active disease. This tailored approach allowed patients to receive less frequent doses if their B-cell counts…

The approved dosage of the multiple sclerosis (MS) therapy Ponvory (ponesimod) — 20 mg taken by mouth once daily — is appropriate for all adults with relapsing forms of MS, a new analysis of data from the OPTIMUM Phase 3 trial found. That analysis showed there was no…

The Accelerated Cure Project (ACP) for multiple sclerosis (MS) is teaming up with Quest Diagnostics to study how MS patients respond to COVID-19 vaccines. “Understanding the immune response to the COVID-19 vaccine doses in a longer-term study in people with MS will provide tremendous insights into not…

Tysabri (natalizumab) given every six weeks was found to be similarly effective as the standard four-week dosing schedule at stopping nervous system damage in people with relapsing-remitting multiple sclerosis (RRMS). That’s according to the full results of the Phase 3b NOVA clinical trial, which compared Tysabri dosing schedules…

NervGen Pharma has received approval to begin testing multiple ascending doses of NVG-291, its lead therapeutic candidate for multiple sclerosis (MS) and other neurologic conditions, in a Phase 1 trial with healthy volunteers. This multiple ascending dose (MAD) part, in which participants will receive increasing doses of NVG-291…

Low doses selected and underlying inflammatory disease may have confounded the ability of temelimab to significantly affect neuroinflammation in a Phase 2 trial in relapsing-remitting multiple sclerosis (RRMS) patients. GeNeuro‘s investigational MS therapy did, however, show other evidence of clinical benefit that supports its continued development, researchers…

Gilenya (fingolimod) at its approved 0.5 mg daily dose continues to be the optimal dose for people with relapsing-remitting MS (RRMS), a systematic review of 11 clinical trials confirmed. A 0.25 mg/day dose, however, also showed improvement over placebo in MRI outcomes and patient satisfaction, the researchers noted, and further…

Interim data from a Phase 2 trial of Immunic Therapeutics’ investigational oral therapy IMU-838 (vidofludimus calcium) in relapsing-remitting multiple sclerosis (RRMS) patients has established a once-daily, 30 mg dose as the most appropriate for future Phase 3 trials. The…

A Phase 1 clinical trial investigating ANK-700 as a means to restore immune tolerance to myelin in people multiple sclerosis (MS) has begun dosing participants. Currently recruiting at a single site in Tennessee, the trial (NCT04602390) is expected to enroll up to 40 patients with relapsing-remitting…

To potentially increase the effectiveness of COVID-19 vaccines in people with multiple sclerosis (MS), the National Multiple Sclerosis Society is recommending dosing adaptations for some disease-modifying therapies (DMTs). Based on expert consensus and available data, the guidance is particularly relevant for MS patients considering initiating or already being…

A twice-daily dosing schedule and side effects like nausea and flushing are key reasons why more than 10% of multiple sclerosis (MS) patients followed for a year stopped using Tecfidera (dimethyl fumarate) as prescribed, a single-site study reports. Adherence to treatment is key to patients’ health, and doctors should not…

New data suggests that treatment with Tysabri (natalizumab) in an extended interval dosing regimen is associated with a significantly lower risk of progressive multifocal leukoencephalopathy (PML) in patients with multiple sclerosis (MS), compared with the standard interval dosing. The data was presented by Lana Zhovtis Ryerson, MD, on May 7 at the 2019 …

Axim Biotechnologies announced that it has succeeded in microencapsulating cannabinoids (chemical compounds in cannabis) into the company’s patented chewing gums, which are used to treat several disease symptoms, including pain and spasticity associated with multiple sclerosis (MS). Since the active cannabinoids are degradable in the body, the company needed…

Biogen announced the start of a global Phase 3b clinical trial to evaluate the efficacy and safety of extended interval dosing (EID) with Tysabri (natalizumab) in patients with relapsing-remitting multiple sclerosis (RRMS). Results of the six-week dosing interval will be compared with the approved standard interval dosing…

Use of medicinal cannabis may pose risks as it may trigger psychiatric problems, but also because it lacks standardized chemical composition, according to a study published in the Journal of the American Osteopathic Association. With the legalization of cannabis in some states for medicinal and recreational proposes, additional pressure…

Multiple sclerosis (MS) patients being treated with dronabinol, a cannabinoid, do not show signs of drug abuse or dependency, leading researchers to conclude it has potential to be a long-term and safe treatment option for neuropathic pain. The issue of pain management, specifically central neuropathic pain (CNP), in patients with autoimmune disorders…

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…

Here’s my pick of this week’s news, as published in Multiple Sclerosis News Today. How Tecfidera Works to Reduce MS Relapses Finally Discovered, May Lead to Better Treatments The possibility that this discovery may lead to the development of new drugs with fewer side effects is good news.