Mallinckrodt to Present Pilot Data On H.P. Acthar Gel For SLE Treatment

Ines Martins, PhD avatar

by Ines Martins, PhD |

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Mallinckrodt Pharmaceuticals recently announced that results from a pilot clinical study for its H.P. Acthar Gel will be presented during the 2015 Annual Meeting of the American College of Rheumatology (ACR) that will take place in San Francisco from 7th until the 11th of November.

The pilot clinical trial entitled “Repository Corticotropin Injection (H.P. Acthar Gel) Attenuates Disease Activity in Patients with Persistently Active Systemic Lupus Erythematosus (SLE) Requiring Corticosteroids,” was a randomised, double-blind, placebo-controlled trial that examined the efficacy of H.P.Acthar Gel during eight weeks in a group of patients with persistently active SLE despite being treated with moderate corticosteroid dosages.

H.P. Acthar Gel (repository corticotropin injection) is indicated during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus (SLE) and is approved by the U.S. Food and Drug Administration (FDA).

Study lead investigator, Richard A. Furie, M.D., who is the Chief of the Division of Rheumatology, Hofstra North Shore LIJ School of Medicine, Great Neck, New York, will present a poster with clinical results on the 8th of November, with the abstract open to consultation on the ACR website. “We are pleased that Dr. Furie will share the first results of our pilot study on the effects of Acthar in patients with this challenging disease at the upcoming ACR Annual Meeting,” said Steven Romano, M.D., Senior Vice President and Chief Scientific Officer of Mallinckrodt. “Mallinckrodt is focused on completing this important clinical study to determine the benefits of Acthar for lupus patients who often have exhausted other good therapeutic options for this difficult-to-treat condition.”

Systemic lupus erythematosus (SLE) is an autoimmune disease in which the body’s immune system mistakenly attacks healthy tissue. It can affect the skin, joints, kidneys, brain, and other organs, with the underlying cause of autoimmune diseases not fully understood. SLE is much more common in women than men and may occur at any age, but appears most often in people between the ages of 10 and 50. African Americans and Asians are affected more often than people from other races.