July 3, 2018 PR-M07-18-NI-009
-- Target enrollment of 230 patients exceeded --
-- Mallinckrodt continues expanding evidence on potential utility of H.P. Acthar Gel in appropriate patients --
STAINES-UPON-THAMES, United Kingdom /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced it has completed enrollment of the company's ongoing Phase 4 clinical trial of H.P. Acthar® Gel for Rheumatoid Arthritis (RA) patients. The study is assessing the efficacy and safety of H.P. Acthar Gel in RA patients with persistently active disease. Target enrollment was 230 patients, and that goal has been exceeded.
"This is an exciting milestone achievement in this important clinical trial," said Steven Romano, MD, Executive Vice President and Chief Scientific Officer at Mallinckrodt. "As prescribers consider the potential benefit H.P. Acthar Gel may provide for appropriate RA patients with persistent disease activity, we are hopeful the findings from this study will help guide those decisions."
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).
Mallinckrodt recently reported interim findings of the study at the Annual European Congress of Rheumatology (EULAR 2018). Details on that data presentation are available here. As the study continues to progress, the company plans to present additional data at future conferences.
Mark Trudeau, President and Chief Executive Officer at Mallinckrodt, said, "Our clinical programs for H.P. Acthar Gel are conducted specifically to further establish its clinical utility in tough-to-treat patient populations, including approved, later-line indications outside infantile spasms, where the drug is considered standard of care. It is our intent to use the data from these programs to better inform prescribers, facilitating access for appropriate patients in both commercial plans and government programs."
Study Details
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 has completed enrollment. 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 trial is fully enrolled, and all subjects are patients with persistently active RA despite treatment with corticosteroids and conventional synthetic and/or biologic disease-modifying anti-rheumatic drugs (DMARDs) 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.
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.1 Treatment is aimed at stopping inflammation to put the disease in remission and relieve symptoms.2 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.
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
Contraindications
Warnings and Precautions
Adverse Reactions
Other adverse events reported are included in the full Prescribing Information.
Please see full Prescribing Information.
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.
CONTACTS
Investor Relations
Daniel J. Speciale, CPA
Investor Relations and Strategy Officer
314-654-3638
daniel.speciale@mnk.com
Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mnk.com
Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mnk.com
Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodtcompany. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2018 Mallinckrodt. US-1800050 06/18
1 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. |
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2 Arthritis Foundation. Rheumatoid Arthritis Treatment. Available at: http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/treatment.php. Accessed June 8, 2018. |
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