STAINES-UPON-THAMES, United Kingdom, Nov. 12, 2019 /PRNewswire/ -- Mallinckrodt Pharmaceuticals plc (NYSE: MNK), a global biopharmaceutical company, today announced data on patient-reported outcomes (PROs) showing Acthar Gel (repository corticotropin injection) improved disease measures that impact rheumatoid arthritis (RA) patients with persistently active disease, as well as new data from an exploratory analysis.The data originate from new analyses from Mallinckrodt's Phase 4 study of Acthar Gelin RA patients with persistently active disease and was recently presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, held Nov. 8-13 in Atlanta.

The study posters can be accessedhereon the company's website.

Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides. ActharGel is approved by theU.S. Food and Drug Administration(FDA) 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).1 Please see Important Safety Information for Acthar Gel below.

"Patient-reported outcomes, like fatigue, pain, and physical functioning, are an important part of any trial assessing clinical treatment outcomes. These additional data shed light on managing this challenging patient population whose symptoms persist after use of first-line therapies and suggest Acthar Gel treatment improved PROs in patients with persistently active RA," said Dr. Nancy E. Lane, Distinguished Professor of Medicine, Rheumatology and Aging, and Director of the UC Davis Center for Musculoskeletal Health. "The data exploring the effect of Acthar Gel treatment on patient-reported outcomes may help clinicians better understand Acthar Gel's use for patients with difficult-to-manage RA, those who have continued symptoms following standard therapies. The need for additional treatment options in this patient population is critical."

Patient-Reported Outcomes and Impact of Treatment (Abstract #439)

New data from the company's two-part Phase 4 multicenter, placebo-controlled study assessing the efficacy and safety of Acthar Gel in patients with persistently active RA who were previously treated with disease-modifying anti-rheumatic drugs (DMARDs) and corticosteroids showed that Acthar Gel treatment significantly improved patient-reported pain, fatigue, physical functioning and work-related impairment as early as Week 4, and resulted in clinically meaningful improvements in PROs.

The analysis examined PRO measures as a secondary endpoint from Part 1 of the study, the 12-week open-label period, and assessed mean changes at baseline and at Weeks 4, 8 and 12.

Patient-Reported Outcomes From the 12-Week Open-label RCI Treatment Perioda,2

PRO Assessment

Baseline, Mean(SD)

Week 4

Week 8

Week 12

Mean Change From Baseline (SD)

FACIT-F

22.8 (8.4)

5.0 (8.2)*

6.5 (8.4)*

8.7 (8.4)*

HAQ-DI

1.7 (0.6)

0.5 (0.5)*

0.6 (0.6)*

0.84 (0.6)*

Patient global assessment of disease activityb,3

63.4 (20.0)

17.8 (23.6)*

25.7 (25.2)*

35.0 (27.3)*

WPAI-RA

Percent work time missed due to RAc

24.9 (27.6)

7.0 (26.6)

5.2 (28.0)

10.8 (26.5)**

Percent impairment while working due to RAc

50.3 (27.1)

18.7 (24.4)*

18.0 (23.9)*

25.2 (25.3)*

Percent overall work impairment due to RAc

58.1 (28.6)

17.6 (27.0)*

17.6 (27.5)*

25.5 (29.2)*

Percent activity impairment due to RAc

63.2 (24.2)

18.1 (24.3)*

22.5 (25.3)*

32.8 (27.4)*

Patient global assessment of paind

64.9 (20.4)3

20.8 (23.3)*

27.6 (25.3)*

37.4 (27.4)*

*p<0.001 vs baseline. **p=0.003 vs baseline.

amITT population (all patients who received study drug and had any post-treatment efficacy assessment).

bMCID = 15% absolute/20% relative improvement.

cMCID = 7% absolute change.

dMCID = 11.

Abbreviations and MCID references: FACIT-F; Functional Assessment of Chronic Illness Therapy Fatigue (MCID = 3-41); HAQ-DI, Health Assessment Questionnaire Disability Index (MCID = 0.2); MCID, minimum clinically important difference; mITT, modified intent-to-treat; PRO, patient-reported outcome; RCI, repository corticotropin injection; SD, standard deviation; WPAI-RA, Work Productivity and Activity Impairment Questionnaire Rheumatoid Arthritis.

AEs observed in the Phase 4 study were consistent with those in previous trials of Acthar Gel.

Study Limitations

"Mallinckrodt remains committed to the rheumatology community and to improving the lives of patients with autoimmune-mediated diseases like RA who continue to have debilitating symptoms and disease exacerbations despite standard treatments," saidSteven Romano, M.D., Chief Scientific Officer and Executive Vice President atMallinckrodt. "We are pleased to be at this year's ACR Annual Meeting to present new data on Acthar Gel that will broaden our understanding of its utility in rheumatology clinical practice for patients with difficult-to-manage RA and areas of high unmet need."

Assessment of Bone and Cartilage Turnover Markers (Abstract #528)

A new exploratory analysis from the Phase 4 RA study assessed bone markers associated with bone loss to evaluate the impact of Acthar Gel treatment on bone turnover in patients with persistently active RA. Bone and cartilage biomarker levels were evaluated throughout the study, at baseline and Weeks 12 and 24 and included: C-terminal cross-linking telopeptide (CTX), C-terminal cross-linking telopeptide of type I collagen (CTX-I), osteoprotegrin (OPG), N-terminal propeptide of type I collagen (PINP), and soluble receptor activator of nuclear factor kappa- ligand (sRANKL) and cartilage degradation biomarkers (C-terminal cross-linking telopeptide of type II collagen (CTX-II) and CTX-II creatinine (CRT).

At Week 12, the open-label period, significant decreases in mean levels of the bone turnover biomarker PINP (P<0.01) and mean levels of cartilage degradation biomarkers CTX-II (P<0.01) and CTX-II CRT (P<0.001) were observed. At Week 24, the end of the study's double-blind period, there was a significant increase from baseline in mean sRANKL levels at both Week 12 and Week 24 (P<0.05) compared to placebo, suggesting a potential increase in osteoclast differentiation. Mean levels of all other bone and cartilage biomarkers remained stable at all time points and markers of bone degeneration remained stable.5

Results from the full RA study were presented earlier this year at the Annual European League Against Rheumatism (EULAR 2019) in Madrid in June. More information on the Phase 4 RA study can be found here on ClinicalTrials.gov.

About Rheumatoid ArthritisRA is an autoimmune disease. It is a chronic condition that causes pain, stiffness, and swelling of the jointsall symptoms caused by inflammation.6 An estimated 1.5 million U.S. adults are living with RA.7 Treatment is aimed at stopping inflammation to put the disease in remission and relieve symptoms.8 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.8

Acthar Gel (repository corticotropin injection)IndicationsActhar Gel is an injectable drug approved by theFDAfor 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 fullPrescribing Information.

ABOUTMALLINCKRODTMallinckrodt 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 reportable 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 reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit http://www.mallinckrodt.com.

Mallinckrodtuses 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 theU.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 STATEMENTSThis 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 ofMallinckrodt'smost recent Annual Report on Form 10-K and other filings with theSEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof andMallinckrodtdoes 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.

CONTACTSFor Trade Media InquiriesCaren BegunGreen Room Communications201-396-8551caren@greenroompr.com

For Financial/Dailies Media InquiriesDaniel YungerKekst CNC212-521-4879mallinckrodt@kekstcnc.com

Investor RelationsDaniel J. Speciale, CPAVice President, Investor Relations and IRO314-654-3638daniel.speciale@mnk.com

Mallinckrodt, the "M" brand mark and theMallinckrodt Pharmaceuticalslogo are trademarks of aMallinckrodtcompany. Other brands are trademarks of aMallinckrodtcompany or their respective owners.2019Mallinckrodt.US-1901844 11/19

References

1ActharGel (repository corticotropin injection) [prescribing information].Mallinckrodt ARD LLC.

2Data on File, Mallinckrodt, 2019. Furst D, Wan G, Liu J, Zhu J, Bartels-Peculis L, Panaccio M, Fleischmann R. Improved Patient-Reported Outcomes in Patients with Persistently Active Rheumatoid Arthritis Following Treatment with Repository Corticotropin Injection. Poster presented at: 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting November 8-13, Atlanta, GA.

3Data on File, Mallinckrodt, 2019. Furst D, Wan G, Liu J, Zhu J, Bartels-Peculis L, Panaccio M, Fleischmann R. Improved Patient-Reported Outcomes in Patients with Persistently Active Rheumatoid Arthritis Following Treatment with Repository Corticotropin Injection [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/improved-patient-reported-outcomes-in-patients-with-persistently-active-rheumatoid-arthritis-following-treatment-with-repository-corticotropin-injection/. Accessed November 8, 2019.

4Fleischmann 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.

5 Data on File, Mallinckrodt, 2019. Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. Assessment of Bone and Cartilage Turnover Markers Following Treatment With Repository Corticotropin Injection in Patients With Persistently Active Rheumatoid Arthritis. Poster presented at: 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting November 8-13, Atlanta, GA.

6 Mayo Clinicwebsite. Rheumatoid Arthritis. Overview. Available at:https://www.mayoclinic.org/diseases-conditions/rheumatoid-arthritis/symptoms-causes/syc-20353648. AccessedNovember 5, 2019.

7 What is Rheumatoid Arthritis?Arthritis Foundation. Available at:http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php. AccessedNovember 5, 2019.

8 Arthritis Foundation. Rheumatoid Arthritis Treatment. Available at:http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/treatment.php. AccessedNovember 5, 2019.

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