Coya Therapeutics is preparing to launch a Phase 2 clinical trial in the U.S. to test its COYA 302 as an amyotrophic lateral sclerosis (ALS) treatment. The company said the U.S. Food and Drug Administration accepted its investigational new drug (IND) application after it submitted additional data the agency…
An experimental oral therapy for amyotrophic lateral sclerosis (ALS) that’s being developed by Athira Pharma was shown to be safe and well tolerated in healthy volunteers who took part in a Phase 1 clinical trial, and the treatment entered the participants’ brain and spinal cords at dose-proportional levels.
For a rare type of amyotrophic lateral sclerosis (ALS), inhibiting a cellular stress response can normalize processes and function in specialized nerve cells called motor neurons, suggesting this response is a possible therapeutic target, a study reports. These results are specific to ALS related to the P56S Â mutation in…
Being exposed to rhodamine B (RhB), a toxic fluorescent dye, causes neurodegeneration and symptoms that resemble amyotrophic lateral sclerosis (ALS) in zebrafish, a study reports. The exposed zebrafish exhibited behaviors, and cellular and molecular changes similar to those in neurological disorders like ALS. Their muscles and motor abilities also…
A new coalition aims to use artificial intelligence (AI) tools to accelerate drug discovery for amyotrophic lateral sclerosis (ALS) and other neurodegenerative disorders. Answer ALS is teaming with partners including GATC Health — a drug discovery company focusing on machine learning and neural networks — Louisiana State…
China’s Center for Drug Evaluation (CDE) has approved a request by Zhimeng Biopharma to launch a Phase 2/3 study of its experimental therapy CB03-154 in people with amyotrophic lateral sclerosis (ALS). The oral treatment, which is designed to slow disease progression by reducing nerve cell overactivity, is also…
The U.S. Food and Drug Administration (FDA) has granted fast track designation to AMX0114, an experimental therapy being developed by Amylyx Pharmaceuticals, for the treatment of amyotrophic lateral sclerosis (ALS). Fast track status is designed to facilitate the development and review of treatments that have the potential to address…
Brainstorm Cell Therapeutics is partnering with Minaris Advanced Therapies to manufacture NurOwn (debamestrocel), its investigational cell therapy for amyotrophic lateral sclerosis (ALS), for an upcoming Phase 3b clinical trial. The companies signed a letter of intent outlining the collaboration, under which Minaris, a contract development and manufacturing…
ATH-1105, an experimental oral therapy for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, was found to be safe and well tolerated in healthy volunteers, according to the treatment’s developer, Athira Pharma. The data comes from a first-in-human Phase 1 trial (NCT06432647) that tested the safety and pharmacological…
Neurosense Therapeutics said it’s scaled production of PrimeC, its oral therapy for amyotrophic lateral sclerosis (ALS), to commercial levels as it awaits regulatory approval to launch the medication in Canada. “This manufacturing milestone represents a critical leap forward in our commercialization roadmap,” Alon Ben-Noon, CEO of Neurosense, said in…
