Mallinckrodt's Phase 2 clinical study involving H.P. Acthar Gel to evaluate the effectiveness of the medication on patients who have Amytropic Lateral Sclerosis (ALS) will begin in 2017.
"We recently completed our pilot study of Acthar in ALS patients, and are pleased to report that the primary objectives of the study were met. The trial explored the safety and tolerability of four potential Acthar dosing regimens in ALS patients," Mallinckrodt Executive Vice President Dr. Steven Romano said. "Although the pilot study was not designed to generate controlled evidence regarding efficacy, we conducted a number of exploratory analyses, including a comparison of the course of disease observed in a small set of patients continuing on Acthar for 36 weeks versus a historical, placebo-treated population."
Differences observed suggested further study was appropriate.
"The study data have also allowed us to select a dose regimen to study the drug further in a rigorous controlled trial," Romano said. "This next proof-of-concept study will evaluate the effects of Acthar on established measures of disease symptoms and progression, enabling us to assess the potential value Acthar may bring to patients with this devastating disease."