Cognixion’s flagship device Cognixion ONE Axon, a product designed to improve communication in people with severe motor impairments, has beed granted breakthrough device designation by the U.S. Food and Drug Administration (FDA). The wireless device is specifically designed for people with people with amyotrophic lateral sclerosis (ALS)…
News
MRI scans of the brains of people with amyotrophic lateral sclerosis (ALS) have identified a neurochemical called N-acetyl aspartate (NAA) whose levels correlate with the loss of motor function, a study reports. A drop in NAA levels was associated with the breakdown in communication between the primary motor cortex…
Cellenkos has dosed the first patient in the Phase 1/1b clinical trial that’s evaluating its regulatory T-cell-based therapy CK0803 for the treatment of amyotrophic lateral sclerosis (ALS). The patient will be one of six participants included in the Phase 1 run-in period of the REGALS clinical trial…
Health Canada has resumed its review of AB Science’s application seeking approval of masitinib, an oral add-on therapy for amyotrophic lateral sclerosis (ALS), after the agency halted its review late last year. In 2022, the agency agreed to review the application under the notice of compliance with…
Apellis Pharmaceuticals has discontinued treatment with pegcetacoplan (APL-2), its investigational therapy for amyotrophic lateral sclerosis (ALS), in the open-label stage of the MERIDIAN trial. The decision follows a review of trial data by an independent data monitoring committee, which concluded that the available results did not…
An early clinical trial is testing whether fecal microbiota transplants (FMT) — a procedure that aims to introduce healthy bacteria to the digestive tract — might reduce inflammation among people with amyotrophic lateral sclerosis (ALS). “With this information, we could potentially provide new approaches for treatments by altering or…
Masitinib as an oral add-on therapy to Rilutek (riluzole) showed the greatest benefits in amyotrophic lateral sclerosis (ALS) patients with mild or moderate disease severity, an analysis of trial data showed. The findings come from the now-complete AB10015 Phase 2/3 clinical trial (NCT02588677) that excluded people…
The bipartisan Senate ALS Caucus has been reestablished to heighten awareness of the needs of those living with amyotrophic lateral sclerosis (ALS), advance policies, improve patient support, and advocate for research investments. U.S. Sens. Chris Coons, D-Delaware, and Mike Braun, R-Indiana, reintroduced the caucus, which is now expanded with…
The recent conditional approval of Qalsody (tofersen) for adults with amyotrophic lateral sclerosis (ALS) who carry mutations in the SOD1 gene is a major cause for celebration, according to the Muscular Dystrophy Association (MDA). The therapy earned accelerated approval from the U.S. Food and Drug Administration (FDA)…
A Phase 2b trial that’s testing PrimeC in people with amyotrophic lateral sclerosis (ALS) has reached 80% enrollment and is on track to complete patient recruitment by June, NeuroSense Therapeutics announced in a quarterly update. Called PARADIGM (NCT05357950), the study began enrolling ALS patients in…
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