The U.S. Food and Drug Administration (FDA) is funding several novel research projects related to amyotrophic lateral sclerosis (ALS) and other rare neurological disorders through its orphan drug grants program. In total, the regulatory agency has awarded 19 new grants and two contracts, providing more than $38 million…

The Wyss Center for Bio and Neuroengineering is planning to launch a trial of its wireless brain computer interface (BCI), called ABILITY, in enabling people to communicate using only their thoughts. The study is expected to involve people in locked-in states — in which they are fully aware, but unable to…

Dazucorilant, Corcept Therapeutics‘ investigational cortisol modulator for people with amyotrophic lateral sclerosis (ALS), is being evaluated in a Phase 2 clinical trial. The DAZALS Phase 2 study (NCT05407324) aims to determine dazucorilant’s safety and efficacy against a placebo in about 198 adults with ALS. It will be…

A cholesterol-related protein, called apolipoprotein A1 (ApoA1), can prevent the death of endothelial cells — those lining blood vessel walls — in a cell model of amyotrophic lateral sclerosis (ALS), a recent lab study shows. According to researchers, these results “show promise for ApoA1 as a therapeutic agent to…

The U.S. Food and Drug Administration (FDA) is extending by three months its review of tofersen, Biogen’s investigational treatment for forms of amyotrophic lateral sclerosis (ALS) caused by mutations in the SOD1 gene. Earlier this summer, the FDA granted the application priority review, with a decision expected no…

The nonprofit EverythingALS is teaming up with several biotech companies for a study into the feasibility of monitoring amyotrophic lateral sclerosis (ALS) progression in people via disease-specific biomarkers captured digitally at the home. The study will be open to adults with an ALS diagnosis or for whom ALS…

An extended-release formulation of PrimeC, an investigational combination therapy for amyotrophic lateral sclerosis (ALS), demonstrated a favorable pharmacokinetic profile in healthy adults in a Phase 1 trial, helping with an ongoing Phase 2b study and work into a potential pivotal trial in ALS patients. A pharmacokinetic (PK) study aims…

Helixmith has unveiled its new multi-approach program called DART — Defeating ALS through Regenerative Therapeutics — to develop new therapies for amyotrophic lateral sclerosis (ALS). Company CEO Sunyoung Kim presented the program in person and virtually at the 2022 Cell & Gene Meeting on the Mesa, Oct. 11–13.

NurOwn, Brainstorm Cell Therapeutics’ investigational cell-based therapy, leads to meaningful disease-related biomarker changes regardless of amyotrophic lateral sclerosis (ALS) severity at the start of treatment, according to data from a Phase 3 trial. Specifically, the therapy increased neuroprotection biomarker levels and anti-inflammatory molecules, and reduced those of neurodegeneration…

The COURAGE-ALS Phase 3 trial of Cytokinetic’s experimental therapy reldesemtiv in people with amyotrophic lateral sclerosis (ALS) will continue as planned following its first planned interim analysis. A data monitoring committee met to review the trial’s data so far with the goal of assessing futility, or whether the…