STAINES-UPON-THAMES, United Kingdom, May 29, 2019 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a global specialty biopharmaceutical company, is reporting data1 from the open-label part of the Phase 4, multicenter study assessing the efficacy and safety of Acthar® Gel (repository corticotropin injection) in patients with persistently active rheumatoid arthritis (RA) who were previously treated with disease-modifying anti-rheumatic drugs (DMARDs) and corticosteroids. The data will be reported in a poster presentation on Thursday, June 13 at the European Congress of Rheumatology 2019 (EULAR), June 12-15 in Madrid.
As previously announced, both parts of the multicenter study are now complete (open-label portion, n=259; controlled, double-blind, randomized portion, n=154).
The Phase 4 study, "A Multicenter Study Assessing the Efficacy and Safety of Repository Corticotropin Injection in Patients With Rheumatoid Arthritis: Interim Data From the Open-Label Treatment Period" abstract can be accessed here.
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 RA, including juvenile RA (selected cases may require low-dose maintenance therapy).
"We are encouraged by the open-label results from this study of Acthar Gel's utility in RA and look forward to sharing the double-blind, randomized part of the study to further measure its effect against this aggressive disease," 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. "Therapies are greatly needed for patients with RA whose disease persists, as measured by validated disease activity metrics, despite use of multiple standard treatments."
Key Findings:
"We are pleased to have completed this important study of Acthar Gel in this underserved population of patients with RA with persistently active disease," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "We are committed to the continued study of Acthar Gel as a therapeutic option for this potentially life-altering form of arthritis that can profoundly impact a person's health and well-being. These clinical trial results are part of our investment into a multi-year Acthar Gel evidence generation effort, and we hope this will be followed by additional data readouts in other difficult-to-manage patient subpopulations."
Study Limitations
About the Study
The study was a Phase 4, multicenter, two-part study assessing the efficacy and safety of Acthar Gel in adult subjects with RA with persistently active disease who were previously treated with corticosteroids and conventional synthetic and/or biologic DMARDs. The primary endpoint of the study was the proportion of patients reaching low disease activity at 12 weeks. The secondary endpoints were (1) to assess the safety and tolerability of Acthar Gel in subjects with RA with persistently active disease and (2) the proportion of participants with low disease activity at 24 weeks.
Part 1 of the study was an open-label period (n=259). After 12 weeks of treatment with Acthar Gel, subjects were evaluated for treatment response using the DAS28-ESR1. In Part 2 of the study (n=154), participants who achieved low disease activity of DAS28-ESR <3.2 at Week 12 in Part 1 entered a double-blind period, randomized in a 1:1 ratio to receive either Acthar Gel or matching placebo for an additional 12 weeks.
Results from the controlled, double-blind phase of the study are targeted for presentation at a research meeting later this year.
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.3 An estimated 1.5 million U.S. adults are living with RA.4 Treatment is aimed at stopping inflammation to put the disease in remission and relieve symptoms.5 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.
Acthar Gel (repository corticotropin injection) Indications
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
Contraindications
Warnings and Precautions
Adverse Reactions
Other adverse events reported are included in the full Prescribing Information.
Please see full Prescribing Information.
ABOUT MALLINCKRODT
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reporting segment's 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. Its Specialty Generics reporting segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning Acthar Gel including expectations regarding its potential impact on patients and anticipated benefits associated with its use. 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.
CONTACTS
For Trade Media Inquiries
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Green Room Communications
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caren@greenroompr.com
For Financial/Dailies Media Inquiries
Daniel Yunger
Kekst CNC
212-521-4879
mallinckrodt@kekstcnc.com
Investor Relations
Daniel J. Speciale, CPA
Vice President, Investor Relations and IRO
314-654-3638
daniel.speciale@mnk.com
References
1 Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. A multicenter study assessing the efficacy and safety of repository corticotropin injection in patients with rheumatoid arthritis: interim data from the open-label treatment period. EULAR 2019.
2 Fleischmann R, Furst DE, Brasington R, Connolly-Strong E, Liu J, Barton ME. 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. Poster presented at: American College of Rheumatology and Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting; October 19-24, 2018; Chicago, IL.
3 Mayo Clinic website. Rheumatoid Arthritis. Overview. Available at: https://www.mayoclinic.org/diseases-conditions/rheumatoid-arthritis/symptoms-causes/syc-20353648. Accessed October 11, 2018.
4 What is Rheumatoid Arthritis? Arthritis Foundation. Available at: http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php. Accessed September 10, 2018.
5 Arthritis Foundation. Rheumatoid Arthritis Treatment. Available at: http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/treatment.php. Accessed September 10, 2018.
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