Mallinckrodt (MNK) Affirms Enrollment of First Patient in H.P. Acthar Gel Phase 4 as SLE Treatment

November 14, 2016 4:32 PM EST

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Mallinckrodt plc (NYSE: MNK) confirmed enrollment of the first patients in the company's Phase 4 clinical study assessing the efficacy of H.P. Acthar® Gel (repository corticotropin injection) in Systemic Lupus Erythematosus (SLE) patients with persistently active disease. This randomized, double-blind, placebo-controlled trial builds on data from a pilot study of H.P. Acthar Gel in patients with active SLE, recently published online in the journal Lupus Science & Medicine in a manuscript titled "Efficacy and tolerability of repository corticotropin injection in patients with persistently active SLE: results of a phase 4, randomized, controlled pilot study."

H.P. Acthar® Gel is approved by the U.S. Food and Drug Administration (FDA) for use during an exacerbation or as a maintenance therapy in select patients with SLE.1

"The data generated in our pilot clinical study support the use of Acthar to treat lupus patients – for which it is already indicated - who have clinically significant disease activity despite receiving standard of care therapies," said Steven Romano, M.D., Chief Scientific Officer and Executive Vice President at Mallinckrodt. "We are pleased to enroll the first patient in this follow-on trial, which will generate additional data to better understand how clinicians may utilize Acthar in the management of these more difficult to manage patients with SLE."



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