Mallinckrodt (MNK) to Initiate Company-Sponsored Clinical Trial of Acthar in ALS; FDA Grants Fast Track Status

November 21, 2016 7:02 AM EST

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Mallinckrodt plc (NYSE: MNK) confirmed that it will initiate a company-sponsored, Phase 2 proof-of-concept clinical trial to assess the efficacy of H.P. Acthar® Gel (repository corticotropin injection) in patients with Amyotropic Lateral Sclerosis (ALS, also known as Lou Gehrig's disease). The study is expected to begin in the first half of 2017.

Mallinckrodt also announced the U.S. Food and Drug Administration (FDA) has granted the company's request for a Fast Track designation for its Acthar Investigational New Drug (IND) application in patients with ALS. The company is working closely with the FDA as it establishes the Phase 2 study design.

"We recently completed our pilot study of Acthar in ALS patients, and are pleased to report that the primary objectives of the study were met. The trial explored the safety and tolerability of four potential Acthar dosing regimens in ALS patients," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "Although the pilot study was not designed to generate controlled evidence regarding efficacy, we conducted a number of exploratory analyses, including a comparison of the course of disease observed in a small set of patients continuing on Acthar for 36 weeks versus a historical, placebo-treated population. Differences observed suggested further study was appropriate. The study data have also allowed us to select a dose regimen to study the drug further in a rigorous controlled trial. This next proof-of-concept study will evaluate the effects of Acthar on established measures of disease symptoms and progression, enabling us to assess the potential value Acthar may bring to patients with this devastating disease."

The FDA's Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. The Fast Track program addresses a broad range of serious conditions.

Mallinckrodt's investment into this clinical trial illustrates a tenet of its Acquire to Invest strategy, applying substantial resources on building a robust, organic pipeline.



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