-- Data Presented at Annual European Congress of Rheumatology (EULAR 2018) --
STAINES-UPON-THAMES, United Kingdom – June 16, 2018 – Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today presented preliminary interim data from the company-sponsored Phase 4 clinical trial of H.P. Acthar® Gel for Rheumatoid Arthritis (RA) patients at the Annual European Congress of Rheumatology (EULAR 2018), held in Amsterdam, Netherlands. The study is assessing the efficacy and safety of H.P. Acthar Gel in RA patients with persistently active disease.
The presentation was entitled “A Multicenter Study Assessing the Efficacy and Safety of Repository Corticotropin Injection in patients with Rheumatoid Arthritis: Preliminary Interim Data from the Open-Label Treatment Period,” and the poster can be accessed here.
Tunde Otulana, MD, Chief Medical Officer at Mallinckrodt, said, “Patients with persistently active rheumatoid arthritis may have symptoms and signs of joint inflammation despite the use of disease-modifying therapies and corticosteroids. Mallinckrodt is committed to conducting studies in rheumatoid arthritis patients to better understand the potential utility of H.P. Acthar Gel in affecting persistent disease activity in these individuals and we are encouraged by the interim clinical trial results.”
H.P. Acthar Gel is U.S. Food and Drug Administration (FDA)-approved as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in rheumatoid arthritis including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).
“The goal of treating RA is to achieve remission or low disease activity. The preliminary results of this study suggest that H.P. Acthar Gel may provide benefit to appropriate patients who are experiencing disease activity in spite of treatment with disease-modifying anti-rheumatic drugs and low-dose prednisone,” said Dr. Roy Fleischmann, Co-Medical Director of the Metroplex Clinical Research Center and Clinical Professor of Medicine at the University of Texas Southwestern Medical Center in Dallas. “This study is an important step to determining the efficacy and safety of this treatment for patients with persistently active RA.”
Study Details and Key Findings
The study is a Phase 4, multicenter, two-part study assessing the efficacy and safety of H.P. Acthar Gel in adult subjects with rheumatoid arthritis with persistently active disease that is currently enrolling patients. Part 1 is an Open Label Period in which all eligible subjects receive H.P. Acthar Gel for 12 weeks. After 12 weeks of treatment with H.P. Acthar Gel, subjects will be evaluated for treatment response using the Disease Activity Score 28-joint count Erythrocyte Sedimentation Rate (DAS28-ESR). Subjects who have achieved low disease activity will enter a double-blind randomized maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either H.P. Acthar Gel or matching placebo for an additional 12 weeks.
The goal is to enroll approximately 230 patients with persistently active RA despite treatment with corticosteroids and conventional synthetic and/or biologic disease-modifying anti-rheumatic drugs (DMARDs) at up to 100 sites for the primary outcome. The primary endpoint in this study is the proportion of subjects with DAS28-ESR <3.2 at Week 12. The Secondary Outcome Measures include the proportion of subjects who maintained DAS28-ESR <3.2 from Week 12 through Week 24.2
Find more information about the study here on the ClinicalTrials.gov website.
ABOUT RHEUMATOID ARTHRITIS
RA is an autoimmune disease. It is a chronic condition that causes pain, stiffness, and swelling of the joints—all symptoms caused by inflammation. An estimated 1.5 million U.S. adults are living with RA. Treatment is aimed at stopping inflammation to put the disease in remission and relieve symptoms. Nonsteroidal anti-inflammatory drugs are used to ease symptoms whereas corticosteroids, disease-modifying anti-rheumatic drugs and biologics are used to slow down the disease activity.4
About H.P. Acthar Gel (repository corticotropin injection) Indications
H.P. Acthar Gel is an injectable drug approved by the FDA for the treatment of 19 indications. Of these, today the majority of Acthar use is in these indications:
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Other adverse events reported are included in the full Prescribing Information.
Please see full Prescribing Information.
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning H.P. Acthar Gel including expectations with regard to the study described in this release, as well as future research plans and potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
Daniel J. Speciale, CPA
Investor Relations and Strategy Officer
Senior Communications Manager
Chief Public Affairs Officer
Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2018 Mallinckrodt. ARDUS/01-18/0618/0002 06/18
3 What is Rheumatoid Arthritis? Arthritis Foundation. Available at: http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php. Accessed June 8, 2018.
4 Arthritis Foundation. Rheumatoid Arthritis Treatment. http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/treatment.php. Accessed June 8, 2018.