Mallinckrodt to Begin Phase 4 Trial of HP Acthar Gel for Symptomatic Sarcoidosis

Specialty pharmaceutical company Mallinckrodt (MNK) said Monday that it will conduct a new phase 4, multi-center, randomized, double blind, placebo-controlled study to further assess the efficacy of H.P. Acthar Gel as a therapy option in patients with symptomatic sarcoidosis.

Sarcoidosis is the growth of tiny collections of inflammatory cells in different parts of the body, most commonly the lungs, lymph nodes, eyes and skin.

The company said that this pilot study in 100 patients is being designed as an exploratory evaluation of a subset of the more challenging patients, many of whom may not have responded to multiple previous therapies. The study will help the company better understand and outline for physicians which patients may benefit from a treatment alternative like Acthar – and perhaps those who are not responding to traditional treatments.

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