Neuvivo and the U.S. Food and Drug Administration (FDA) have agreed on a regulatory pathway toward the potential approval of NP001 for amyotrophic lateral sclerosis (ALS), with Phase 3 clinical testing planned for 2026. The details were agreed upon in a Type C meeting and the pivotal…
In amyotrophic lateral sclerosis (ALS), the loss of any one of four RNA-binding proteins turns off a gene called UNC13A that needs to stay active for nerve cells to communicate with each other — with three of them leading to an excess of another protein, REST — pointing to…
Full randomization is nearly complete in the Phase 2/3 COMBAT-ALS trial testing MN-166 (ibudilast) for the treatment of amyotrophic lateral sclerosis (ALS), its developer, Medicinova, reported. Fewer than 10 participants remain to be assigned to a treatment group. The ongoing COMBAT-ALS trial (NCT04057898) aims to evaluate…
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…
AB Science has been cleared to start its confirmatory Phase 3 trial of masitinib for people with amyotrophic lateral sclerosis (ALS) in the U.S. and certain European countries. The company announced plans for the Phase 3 AB23005 trial earlier this year, noting then that the trial…
NKGen Biotech said it’s been cleared to launch an expanded access program (EAP) that will allow patients in the U.S. with neurodegenerative conditions, including amyotrophic lateral sclerosis (ALS), to access its experimental therapy troculeucel outside clinical trials. EAPs, or compassionate use programs, allow people with serious or life-threatening conditions…
The ALS Association has announced the winners of its first-ever Hoffman ALS Clinic Development and Capacity Awards, two new grant programs aimed at improving access to multidisciplinary care for people with amyotrophic lateral sclerosis (ALS) across the U.S. The awards are supported by a $58 million donation from the…
The ongoing program that is providing amyotrophic lateral sclerosis (ALS) patients with access to Medicinova’s investigational therapy MN‑166 (ibudilast) outside of a clinical trial is adding new sites. The expanded access program (EAP) will enroll about 200 patients at several locations in the U.S. who are not eligible…
AUT00201, an experimental oral small molecule being developed by Autifony Therapeutics, reduced the loss of motor neurons — the nerve cells that control movement — and eased motor symptoms in a mouse model of amyotrophic lateral sclerosis (ALS), a new study showed. It was also found to improve…
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…
