Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced it has completed enrollment of the company’s ongoing Phase 4 clinical trial of H.P. Acthar® Gel for Rheumatoid Arthritis (RA) patients. The study is assessing the efficacy and safety of H.P. Acthar Gel in RA patients with persistently active disease. Target enrollment was 230 patients, and that goal has been exceeded.
“This is an exciting milestone achievement in this important clinical trial,” said Steven Romano, MD, Executive Vice President and Chief Scientific Officer at Mallinckrodt. “As prescribers consider the potential benefit H.P. Acthar Gel may provide for appropriate RA patients with persistent disease activity, we are hopeful the findings from this study will help guide those decisions.”
H.P. Acthar Gel is U.S. Food and Drug Administration (FDA)-approved as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in rheumatoid arthritis including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).
Mallinckrodt recently reported interim findings of the study at the Annual European Congress of Rheumatology (EULAR 2018). Details on that data presentation are available here. As the study continues to progress, the company plans to present additional data at future conferences.
Mark Trudeau, President and Chief Executive Officer at Mallinckrodt, said, “Our clinical programs for H.P. Acthar Gel are conducted specifically to further establish its clinical utility in tough-to-treat patient populations, including approved, later-line indications outside infantile spasms, where the drug is considered standard of care. It is our intent to use the data from these programs to better inform prescribers, facilitating access for appropriate patients in both commercial plans and government programs.”