"Pridopidine Phase 3 Trial for ALS Patients Expected This Year"
Prilenia Therapeutics plans to launch a pivotal Phase 3 study of pridopidine, a potential amyotrophic lateral sclerosis (ALS) treatment, following promising Phase 2 trial data showing slower disease progression, improved quality of life, and potential survival prolongation in early-stage ALS patients. Pridopidine, designed to activate the sigma-1 receptor, aims to slow ALS progression by boosting nerve cell function and survival. While the Phase 2/3 trial did not meet its main goal, pridopidine showed significant improvements in speech measures and slowed declines in respiratory function and overall life quality, particularly in early, fast-progressing ALS patients. Pridopidine was well tolerated, and its continued development is supported by an ongoing expanded access program and orphan drug designation in the U.S. and Europe.