News

Phase 2 COMMEND Trial Enrolls ALS Participants After Flex Reports Positive Topline Results

Boston-based Flex Pharma has announced positive topline results from its exploratory Phase 2 trial testing investigational therapy FLX-787 in Australian amyotrophic lateral sclerosis (ALS) patients with frequent muscle cramps. The data showed that FLX-787 significantly reduced the intensity of cramp-associated pain and stiffness compared to placebo. The positive results support the…

Defects in Cell Cleanup System May Lead to ALS and Other Diseases, Mouse Study Shows

Researchers at Germany’s University of Würzburg have discovered how a malfunctioning autophagy – a cell’s natural self-degradation and cleanup system – plays a central role in the development of amyotrophic lateral sclerosis (ALS) and other motor neuron diseases. The study, “Plekhg5-regulated autophagy of synaptic vesicles reveals a pathogenic mechanism…

Biohaven Initiates BHV-0223’s Pivotal Clinical Trial to Demonstrate Bioequivalence to Rilutek

Biohaven Pharmaceutical has dosed the first amyotrophic lateral sclerosis (ALS) patient with its sublingual formulation of riluzole, BHV-0223, in a pivotal Phase 2/3 trial. The trial aims to demonstrate that BHV-0223’s effects are at least equivalent to Rilutek, an approved tablet formulation of riluzole. The trial initiation was supported by…

FDA OKs Biohaven’s Sublingual BHV-0223 for Clinical Investigation

The U.S. Food and Drug Administration (FDA) has given the green light to Biohaven Pharmaceuticals to advance sublingual BHV-0223, which regulates glutamate communication between neurons, into clinical trials for amyotrophic lateral sclerosis (ALS) patients. The FDA’s  permission to go ahead with the study followed Biohaven’s submission of an investigational new drug…