ProJenX is back on the map after the FDA lifted a partial clinical hold on a phase 1 clinical trial for an amyotrophic lateral sclerosis (ALS) drug.
NEW YORK, Feb. 14, 2024 /PRNewswire/ -- ProJenX, a clinical-stage biotechnology company developing novel, brain-penetrant therapies targeting biologically-defined pathways for the treatment of amyotrophic lateral sclerosis (ALS) and other debilitating brain diseases, today announced that it has received authorization in the European Union (EU) for study PRO-101, a hybrid Phase 1 clinical trial evaluating prosetin—a first-in-class MAP4K inhibitor—in healthy volunteers and participants with ALS. Following recent Health Canada authorization of this study, the European authorization will expand the global footprint of Part 1c of PRO-101, designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of prosetin in participants with ALS.