clinical trials

The U.S. Food and Drug Administration (FDA) has accepted an investigational new drug application (IND) for ANK-700, a treatment candidate for multiple sclerosis (MS) that is being developed by the Swiss company Anokion. With this approval, Anokion can enter clinical testing and is planning to…

Upcoming and ongoing clinical trials aim to expand an understanding of Kesimpta (ofatumumab), the Novartis therapy recently approved by the U.S. Food and Drug Administration (FDA) to treat relapsing forms of multiple sclerosis (MS). Kesimpta is an anti-CD20 monoclonal antibody, a type of treatment that is thought to work…

MMJ International Holdings, in collaboration with a a specialty pharmaceutical solutions company, has begun manufacturing gelatin capsule medicines based on compounds found in cannabis, The company will investigate these in clinical trials as potential treatments for multiple sclerosis (MS) and Huntington’s disease. “As MMJ…

GeNeuro announced that a first multiple sclerosis (MS) patient has enrolled in its Phase 2 trial assessing the safety and effectiveness of temelimab in people whose disease is progressing in the absence of relapses. This trial, taking place at the Karolinska Institutet’s Academic Specialist Center (ASC), in Stockholm, had been postponed to reduce…

A first person has enrolled in Sanofi’s Phase 3 trial evaluating SAR442168, an oral BTK inhibitor intended to treat relapsing forms of multiple sclerosis (MS), Sanofi’s partner, Principia Biopharma, announced. “We are delighted that Sanofi has initiated … [this] trial in patients with relapsing MS,” Roy Hardiman, chief…

Atara Biotherapeutics has enrolled a first patient in a clinical trial testing ATA188, its off-the-shelf T-cell immunotherapy for people with progressive forms of multiple sclerosis (MS). The Phase 1b trial (NCT03283826) follows promising safety and tolerability results from its open-label Phase 1a part, including a…

ERT, which specializes in clinical trial data collection, announced it has acquired APDM Wearable Technologies (APDM), a provider of wearables and digital biomarkers, to improve the accuracy of key efficacy measures used in clinical studies of multiple sclerosis (MS), Parkinson’s, and other movement disorders. A…

An international committee of multiple sclerosis (MS) experts further clarified how guidelines, updated in 2013, should be used to classify this disease’s different states, and stressed the importance of measuring these states in a timely and consistent manner. The group’s statement, “The 2013 clinical course descriptors…

Editor’s note: “Need to Know” is a series inspired by common forum questions and comments from readers. Have a comment or question about MS? Visit our forum. This week’s question is inspired by the forum post “I’ve Been Spoiled by My Clinical Trial,” published March 5. Share your…

MMJ International Holdings announced that it has been given clearance to ship its cannabis-based products to the U.S. for use in future clinical trials of potential cannabis-based treatment for multiple sclerosis (MS) and Huntington’s disease. The process was facilitated by the U.S. Drug Enforcement Agency (DEA), which worked alongside…

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…

Sanofi will host an online science session to present results of a Phase 2b clinical trial testing the safety and efficacy of its investigational, oral BTK inhibitor SAR442168 in people with multiple sclerosis (MS). The virtual session, owing to the cancellation of the American Academy…

A planned Phase 2 clinical trial of a potential treatment for progressive multiple sclerosis has been postponed to keep hospital resources open to treat people with COVID-19 during the ongoing global outbreak, and to reduce the risk of exposure to MS patients, GeNeuro, the investigate therapy’s developer, announced. The…

MedDay Pharmaceuticals‘ MD1003 did not ease functional disability or its progression in patients with non-active progressive multiple sclerosis, Phase 3 clinical trial data shows. The SPI2 Phase 3 study (NCT02936037) sought to confirm the positive results of a first Phase 3 trial called MS-SPI…

By the end of this month, another disease-modifying therapy (DMT) for multiple sclerosis may be available in the U.S. Ozanimod is an investigational daily pill for the treatment of relapsing MS. The Food and Drug Administration is expected to decide…

The experimental BTK inhibitor SAR442168 showed an acceptable safety profile and met its primary endpoint — a significant reduction in the number of new lesions visible on a brain imaging scan — in a Phase 2 trial in people with multiple sclerosis (MS), study results show. SAR442168,…

Editor’s note: “Need to Know” is a series inspired by common forum questions and comments from readers. Have a comment or question about MS? Visit our forum. This week’s question is inspired by “Newly Diagnosed MS Patients Show Changes in Gut Microbiome, Study Says,” from Dec. 3, 2019.

The U.S. Food and Drug Administration (FDA) has agreed to allow Myeliviz, an imaging agent of myelin — the protective layer that covers nerve fibers and is damaged in multiple sclerosis (MS) — to be evaluated in a clinical trial with healthy volunteers. Myeliviz, created by Case Western Reserve University researchers, has the potential…

Vitalis will soon test VTS-72, a new formulation of fumarate and VTS-Aspirin, in a Phase 3 trial as a treatment for flushing — facial redness, itching or rash — in patients with relapsing-remitting multiple sclerosis (RRMS). Flushing is a common side effect of an oral MS therapy called…

A new clinical trial is comparing the best available therapies to an experimental stem cell therapy to treat severe forms of relapsing multiple sclerosis (MS). At the moment, more than a dozen therapies have been approved by the U.S. Food and Drug Administration for the treatment of relapsing forms…

Trials testing new immunotherapies for multiple sclerosis (MS) should focus more on patients’ experiences and on symptoms relevant for them such as fatigue, depression, and cognitive difficulties, a German working group recommends. According to the team, which is working on developing new standards for planning MS trials, clinical…

Mount Sinai Medical Center has joined with BrainStorm Cell Therapeutics to explore the safety and efficacy of NurOwn as a potential treatment for progressive multiple sclerosis (MS) in an ongoing Phase 2 trial. The New York center is the fourth clinical site participating in the trial, in addition…

GeNeuro is collaborating with clinical researchers at the Karolinska Institutet and the Academic Specialist Center (ASC) in Stockholm to open a new clinical trial of temelimab in people whose multiple sclerosis (MS) is progressing in the absence of relapses. Fredrik Piehl, MD, PhD, a professor of neurology at…

MMJ International Holdings announced that it has entered into an agreement for the production of its proprietary cannabis-based gel capsule — a product mix of tetrahydrocannabinol (THC) and cannabidiol (CBD) — in compliance with guidelines set by the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA).

A joint analysis of 83 studies, involving 3,000 people, concluded that there is “scarce evidence” to say that the use of medicinal cannabinoids — chemical compounds in the cannabis plant — is able to improve mental health conditions. However, the use of pharmaceutical tetrahydrocannabinol (THC) may lead to…

Editor’s note: This is the second story in a three-part report examining experts’ answers to the question “Should vitamin D supplements be recommended for MS patients?”, which was a topic discussed at this year’s Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Here, we take an in-depth…

EMD Serono (Merck KGaA in Germany) is opening two pivotal and global Phase 3 clinical trials to evaluate the effectiveness and safety of oral evobrutinib in people with relapsing multiple sclerosis (MS). Evobrutinib, also known as M2951, works by blocking a protein called Bruton’s tyrosine kinase (BTK), which is…

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…

Treatment with a potential remyelinating agent called liothyronine was safe and well-tolerated by people with multiple sclerosis (MS) in a Phase 1b trial. Preliminary results also suggested benefits in cognition, motor function, and fatigue. The study, “A Phase 1b, open-label study to evaluate the safety…

NervGen Pharma announced plans to open clinical trials evaluating the potential of its lead candidate NVG-291 to treat multiple sclerosis (MS) and spinal cord injury. NVG-291 is an investigational peptide that has shown an ability to stimulate nerve regeneration following an injury in several animal models of disease.