Tyruko (natalizumab-sztn) is now commercially available in the U.S. as the first and only approved biosimilar to Tysabri for adults with relapsing forms of multiple sclerosis (MS). The therapy received approval from the U.S. Food and Drug Administration (FDA) in 2023 for all indications covered by the…
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…
No added benefit was found in increasing the dose of Genentech’s Ocrevus (ocrelizumab) — to two to three times the currently approved 600 mg dose — in slowing disability progression in adults with relapsing multiple sclerosis (MS), according to new data from a Phase 3 clinical study. The…
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…
Less frequent Ocrevus (ocrelizumab) infusions are as effective as standard dosing — when treatment is given typically every six months — for controlling multiple sclerosis (MS) disease activity, but may help limit the risk of side effects, a new study reports. “These findings suggest that [extended-interval dosing] could…
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…
Viatris has launched a generic version of low-dose Copaxone (glatiramer acetate) in the Canadian market for the treatment of people with relapsing-remitting multiple sclerosis (RRMS) who retain the ability to walk. Called Glatiramer Acetate Injection 20 mg/mL, the product was approved in Canada as a generic of…
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…
Tiziana Life Sciences has dosed four new participants in an expanded access program investigating its foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS), the company announced. A total of 10 SPMS patients are now being followed outside of clinical trials in foralumab’s expanded…
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…
The first participant has completed dosing in a Phase 1 clinical trial testing FSD Pharma‘s Lucid-21-302, an experimental oral medication for all types of multiple sclerosis (MS), in healthy volunteers. After receiving a green light from Health Canada to launch the first-in-human trial, the company began by…
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…
Biogen has secured a new patent in Europe covering the use of its oral therapy Tecfidera (dimethyl fumarate) for multiple sclerosis (MS) through 2028, the company announced. Granted by the European Patent Office, patent EP2653873 covers the composition and use of dimethyl fumarate at a dose of 480…
Regular feedback from doctors about dosing data and health status is associated with high and sustained treatment adherence to Rebif (interferon beta-1a) among multiple sclerosis (MS) patients using the RebiSmart autoinjector, a two-year observational study shows. This study’s level of treatment adherence — 97.9% — was comparable or superior to the…
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…
A higher dose of Copaxone (glatiramer acetate) given three times weekly over seven years led to sustainably lower relapse rates and slowed disability progression in multiple sclerosis (MS) patients, according to a long-term analysis of the GALA study. The higher dose — 40 mg/mL — was generally well-tolerated with no…
The first patient who completed the ProTEct-MS Phase 2 clinical trial assessing temelimab as a treatment for relapsing forms of multiple sclerosis (MS) has entered the trial’s extension part. In the open-label extension trial, patients will switch to or continue to receive temelimab at least until next spring, when…
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…