Phase 2 Trial Will Test Cortisol Modulator Dazucorilant in ALS

Phase 2 Trial Will Test Cortisol Modulator Dazucorilant in ALS

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…

FDA Extends Tofersen Review Period to April 2023

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…

Biomarkers Boosted by NurOwn Regardless of Disease Severity: Data

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…