Neurosense finalizing protocol for Phase 3 ALS trial of PrimeC
Dec 19, 2024 · In PARADIGM (NCT05357950), a completed Phase 2b study, PrimeC was tested against a placebo, both taken as two tablets by mouth twice daily for six months, in 68 adults diagnosed with ALS.Patients then had the option to enter an open-label extension where all received PrimeC for up to an additional 12 months. Consistent with earlier data, the 18-month readout showed that, compared with patients ...
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4 days ago · Diabetes, high cholesterol linked with lower risk of developing ALS. People with diabetes or high cholesterol may be less likely to develop amyotrophic lateral sclerosis (ALS) or other motor neuron diseases (MNDs), but heart and metabolism problems are linked with faster disease progression and worse survival rates among people who already have MND.
First-in-human trial of ALS therapy ASHA-624 expected in early 2025
Nov 20, 2024 · What is ASHA-624? ASHA-624 was designed using Asha’s PRISM platform to “glue” the SARM1 protein, a central regulator of nerve fiber degeneration, into an inactive state, which should prevent the damage that causes motor neurons to die in ALS.. In preclinical models of the disease, ASHA-624 restored motor function to levels similar to healthy controls, while it continued to worsen with a ...
FDA outlines steps to consider accelerated approval of CNM-Au8
Dec 11, 2024 · The therapy’s developer, Clene, said it will put together an application in the coming months, with the goal of submitting it in mid-2025. “We are incredibly grateful for the FDA’s willingness to consider how the available data from our expanded access programs may be able to support the existing clinical study data to allow for the review of an application for approval of CNM-Au8 for ...
Trace Neuroscience launches, aims to develop treatment for ALS
Nov 15, 2024 · Trace Neuroscience kicked off its operations in California with $101 million in Series A financing, which the company will use to continue developing its lead treatment candidate.. That candidate was designed based on research showing that UNC13A, a protein important for nerve cell communication, is deficient in most people with ALS.
Initiative to use AI technologies to improve communication in ALS
Oct 17, 2024 · The Scott-Morgan Foundation (SMF), a nonprofit that’s pioneering assistive technology innovation, will lead a new initiative using artificial intelligence (AI) technologies to help people with diseases like amyotrophic lateral sclerosis (ALS) to better communicate and maintain their sense of identity.
Neuvivo requests FDA approval of ALS treatment NP001
Oct 9, 2024 · The new drug application comes on the heels of combined data from Phase 2a (NCT01281631) and Phase 2b (NCT02794857) clinical trials, in which NP001 slowed disease progression and preserved lung function in a subset of ALS patients with high levels of inflammation.. If approved, NP001 could be the first disease-modifying therapy for ALS designed to restore the balance of the innate immune ...
Corcept's dazucorilant fails to slow ALS disease progression in...
Dec 17, 2024 · The study (NCT05407324), which tested dazucorilant doses at 150 mg or 300 mg in 249 participants, also showed that gastrointestinal side effects at the start of treatment were “substantially” more common with dazucorilant than a placebo.. No deaths were reported in the high-dose group after six months, but five deaths were in the placebo group, a statistically meaningful difference.
Phase 2 trial of ROCK inhibitor Bravyl now fully enrolled
Nov 18, 2024 · While the REAL trial (NTC05218668) was initially slated to only test a 180 mg daily dose of the oral treatment, positive safety and efficacy findings from that group prompted Woolsey Pharmaceuticals to reopen the study and investigate the possible benefits of a 300 mg dose. Results are expected by the middle of next year. “Experience with this higher dose in ALS patients will be invaluable ...
Amyotrophic Lateral Sclerosis (ALS) Symptoms – ALS News Today
Feb 6, 2023 · Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder in which worsening muscle weakness leads to movement problems and other symptoms such as trouble swallowing, speaking, and breathing. Patients also can experience digestive issues, mental health problems, and changes in behavior.