Mallinckrodt Pharmaceuticals issued the following announcement on Jan. 30.
Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, confirmed enrollment of the first patient in the company's Phase 4, multi-center, randomized, double-blind, placebo-controlled pilot study to further assess the efficacy of H.P. Acthar Gel as a therapy option in patients with pulmonary sarcoidosis.
H.P. Acthar Gel is approved by the U.S. Food and Drug Administration (FDA) for the respiratory condition symptomatic sarcoidosis, one of 19 indications.
"I am pleased that the first patient has been enrolled in this important Phase 4 study, the results of which may potentially provide evidence to further support Acthar as a treatment option in appropriate symptomatic sarcoidosis patients," said Dr. Robert Baughman, M.D., Professor in the Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio1. "In my experience, a considerable number of sarcoidosis patients can have persistent disease that may not be resolved by first-line treatment."
"The enrollment of the first patient in this study is an important milestone in our further assessment of Acthar's efficacy as a treatment option for sarcoidosis patients," said Tunde Otulana, M.D., Chief Medical Officer at Mallinckrodt. "We believe this exploratory evaluation of the more challenging patients who may still have disease activity after previous therapies can potentially help physicians better understand which individuals may benefit from the drug as a treatment alternative."
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