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…
FDA outlines steps to consider accelerated approval of CNM-Au8
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…
Life at home with ALS becomes like “Groundhog Day,” the 1993 film starring Bill Murray, in which the main character, Phil, is stuck in a time loop and is forced to live the same day over and over. But there’s something in us that craves novelty, and Phil goes…
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…
Like many ALS patients, I had a difficult time accepting assistive devices into my life. In my case, a pair of ankle-foot orthoses (AFOs), a rollator, and a mobility scooter challenged my adaptability and sense of myself. But over time, with lots of persistence and support from my caregiver…
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…
Recent Posts
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- New funding backs commercial readiness efforts for ALS therapy