News

The U.S. Food and Drug Administration (FDA) signaled that it may be willing to consider granting accelerated approval to CNM-Au8 to treat amyotrophic lateral sclerosis (ALS), based on data from clinical trials and ongoing expanded access programs. The therapy’s developer, Clene, said it will put together an…

MN-166 (ibudilast), an investigational oral treatment for amyotrophic lateral sclerosis (ALS), appears to slow disease progression over up to one year of use, according to an analysis of data in an ongoing Phase 2b/3 clinical trial. The interim analysis, required under the study’s design, looked into how well…

Quralis has dosed the first patient in a Phase 1 clinical trial testing QRL-101 — its treatment candidate for reducing nerve cell overactivation in amyotrophic lateral sclerosis (ALS) and thus potentially slowing disease progression — in adults with ALS. The proof-of-mechanism QRL-101-04 trial (NCT06714396) is still enrolling…

MaaT033, an experimental oral therapy for improving the gut microbiome — the collection of microbes, including bacteria, in the human gut — was deemed safe and well tolerated in people with amyotrophic lateral sclerosis (ALS) after two months of dosing. That’s according to a new analysis from an independent…

The technology company Unlearn is teaming up with APST Research to create “digital twins” to support clinical trials for amyotrophic lateral sclerosis (ALS). Clinical data from more than 8,000 ALS patients in APST’s database will be fed into Unlearn’s Digital Twin Generator (DTG), an artificial intelligence…

Twice-daily treatment with PTC Therapeutics’ oral candidate utreloxastat failed to significantly slow disease progression in adults with amyotrophic lateral sclerosis (ALS) in a global, placebo-controlled Phase 2 clinical trial. The results of CardinALS (NCT05349721) showed that, while the therapy was generally safe, it failed to meet its…

The University Health Network (UHN) in Toronto was selected as the first site in Canada to be part of a clinical trial testing Neuralink‘s brain-computer interface (BCI) in people unable to move their limbs due to amyotrophic lateral sclerosis (ALS) or spinal cord injury. The start of patient…

A Phase 1 clinical trial of QRL-201, Quralis‘ therapy candidate for amyotrophic lateral sclerosis (ALS), has successfully completed its dose-escalation phase, with the two doses tested reaching therapeutic levels in the spinal fluid of patients. The trial, dubbed ANQUR (NCT05633459), is now moving toward a dose range-finding…

People with mutations in the C9ORF72 gene who develop amyotrophic lateral sclerosis (ALS) show signs of damage to certain brain regions years before the appearance of disease symptoms, a study reports. The findings suggest that looking for changes in brain structures could help predict which people with C9ORF72 mutations…

Widetrial, an integrated service and technology platform, is coming on board to support an expanded access program (EAP) that will provide the investigational therapy MN-166 (ibudilast) to amyotrophic lateral sclerosis (ALS) patients who aren’t eligible for clinical trials. The program is funded under a $22 million federal…