BTK inhibitor

Genentech‘s experimental oral therapy fenebrutinib has become the first Bruton’s tyrosine kinase (BTK) inhibitor to show positive Phase 3 results in both relapsing forms of multiple sclerosis (MS) and primary progressive MS (PPMS), the company announced. In what Genentech called “unprecedented results,” two late-stage trials testing…

Zenas Biopharma has acquired global rights to develop the BTK inhibitor orelabrutinib to treat multiple sclerosis (MS) and other diseases. The deal with orelabrutinib’s developer, Innocare Pharma, includes rights to two other investigational therapies. Zenas will pay Innocare up to $100 million in cash and up to…

Fenebrutinib significantly reduced the occurrence of new brain lesions with active inflammation in people with relapsing multiple sclerosis (MS), a Phase 2 clinical trial found. In the open-label extension portion of the FENopta trial (NCT05119569), disease activity “remained very low” for nearly one year, researchers wrote, with 98%…

More than one-third of neurologists in the U.S. believe Bruton’s tyrosine kinase (BTK) inhibitors could be of pivotal significance as a future treatment of multiple sclerosis (MS), according to findings of a recent Spherix Global Insights’ survey. “Through Spherix’s quarterly RealTime Dynamix market tracker, neurologists…

People with multiple sclerosis (MS) of African descent had higher levels of inflammatory B-cells in the fluid around the brain and spinal cord compared with white MS patients in a small U.S. study. These findings may help to explain why Black people with MS tend to experience a faster…

A little over a year ago, I wrote about whether Bruton’s tyrosine kinase inhibitors (BTKi’s) might be the next big thing in multiple sclerosis (MS) treatments. BTKi’s are small molecules that selectively block an enzyme that’s important for the activation of B-cells in the immune system and…

The National Medical Products Administration (NMPA) of China has agreed to approve a Phase 2 trial testing the safety and efficacy of the investigational therapy SN1011 in people with multiple sclerosis (MS). SN1011 is being developed by SinoMab Bioscience to treat a range of autoimmune and inflammatory…

Tolebrutinib, an investigative inhibitor of Bruton’s tyrosine kinase (BTK) being developed by Sanofi to treat all forms of multiple sclerosis (MS), shows the potential to be more potent than other BTK inhibitors also in advanced clinical trials, scientists reported. The findings, based on preclinical data, were shared at the Americas…

In this installment of our “Expert Voices” series, Multiple Sclerosis News Today asked Tim Coetzee, PhD, some of your questions related to the current state of multiple sclerosis (MS) treatment and cure research. Coetzee serves as the National MS Society’s chief advocacy, services, and science officer. In this capacity, he…

Nerve Repair Therapy NVG-291 Safe, Well-tolerated in Healthy People This experimental therapy has a long way to go before it becomes reality. But it’s encouraging that this first step found NVG-291’s side effects to be mild and short-lasting. NVG-291 is designed to promote remyelination by modulating an enzyme called…

Sanofi Genzyme has extended its collaboration with Koneksa to bring digital measures into its Phase 3 trials of tolebrutinib, an investigational therapy for relapsing and progressive forms of multiple sclerosis (MS). Through this joint effort, Koneksa’s digital biomarkers were applied to clinical trials of Parkinson’s…

Treatment with evobrutinib, an experimental therapy for relapsing forms of multiple sclerosis (MS), reduced the size of inflammation-associated brain lesions in a Phase 2 clinical trial, data show. The oral medication was also found to be generally safe and well tolerated, according to an analysis of trial data in…

Is orelabrutinib one of the next big MS therapies? Biogen is betting at least $125 million that it is. Orelabrutinib is an experimental oral BTK inhibitor (BTKi). BTKi’s are designed to selectively block an enzyme that’s important for the activation of B-cells and microglia. Some of those immune cells…

Biogen Strikes Deal for Orelabrutinib, Now in Phase 2 Trial BTK inhibitors, such as orelabrutinib, are designed to selectively block the activity of an enzyme important for the activation of B-cells and microglia. Some of those cells drive the abnormal immune responses that attack the central nervous systems of…

Biogen has signed a deal with InnoCare Pharma to acquire global commercialization and licensing rights to orelabrutinib, an experimental oral BTK inhibitor (BTKi) now being tested in people with relapsing-remitting multiple sclerosis (RRMS) in a Phase 2 clinical trial. Under the terms of the agreement, Biogen will have…

Investigators are looking for people with progressive forms of multiple sclerosis (MS) to participate in two Phase 3 clinical trials assessing the safety and effectiveness of tolebrutinib (SAR442168), an oral BTK inhibitor that is being investigated as a potential treatment, the National Multiple Sclerosis Society announced…

Two global Phase 3 clinical trials, both comparing Sanofi Genzyme’s investigational tolebrutinib with its approved therapy Aubagio, are enrolling a total of 1,800 people with relapsing multiple sclerosis (MS), the company said. All patients in both studies — dubbed GEMINI 1 and GEMINI 2 — will…

InnoCare Pharma is preparing to launch a Phase 2 trial to assess the safety and efficacy of orelabrutinib, its investigational Bruton tyrosine kinase inhibitor, in patients with relapsing-remitting multiple sclerosis (RRMS). The trial, which is expected to enroll approximately 160 patients, will be carried out in the U.S.

Tolebrutinib (SAR442168), an investigational oral BTK inhibitor to treat relapsing forms of multiple sclerosis (MS), was seen to prevent the loss of myelin when given to a mouse model of demyelination in a preclinical study. The investigative therapy achieves this by preventing…

Roche has launched a Phase 3 clinical trial program to evaluate fenebrutinib, its investigational oral BTK inhibitor, in people with relapsing forms of multiple sclerosis (MS) and primary progressive MS (PPMS). Data on fenebrutinib’s potency and selectivity, as well as the design of the clinical…

In a $3.68 billion transaction, Sanofi is preparing to acquire Principia Biopharma, a biopharmaceutical company focused on the development of therapies for disorders caused by dysregulation of the immune system, including multiple sclerosis (MS). The decision was unanimously approved by the board of directors of…

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…

Dietary Changes May Delay Development and Progression of MS, Study Finds Methionine is an amino acid found in meat, eggs, and dairy. It’s absorbed by T-cells that are part of our immune system. Those cells are also believed to be the immune cells that attack our myelin, creating the…

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,…