Mallinckrodt Enrolls First Patient in Phase 1 Study of ExpressGraft™C9T1 Skin Tissue

STAINES-UPON-THAMES, United Kingdom, Feb. 14, 2018 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today confirmed enrollment of the first patient in the company's Phase 1 study assessing the safety and tolerability of ExpressGraft^™C9T1 skin tissue in the treatment of subjects with diabetic foot ulcers (DFUs). ExpressGraft-C9T1 skin tissue has been genetically modified to express elevated levels of the human cathelicidin host defense peptide.

"I am excited that the first patient has been enrolled in this important Phase 1 study. Diabetic foot ulcers and resulting complications can be physically debilitating and lead to emotionally devastating problems in this population," said Thomas E. Serena, MD, FACS, FACHM, MAPWCA, CEO and Medical Director SerenaGroup and lead investigator for the ExpressGraft-C9T1 skin tissue study. "This research may help expand options and further our understanding of diabetic complications related to DFUs."

"Mallinckrodt is committed to providing treatment options for patients with unmet medical needs. Enhancement of antimicrobial action through genetic modification may benefit patients with chronic, difficult-to-heal wounds such as those seen in patients with diabetes," said Lynn Allen-Hoffmann, Senior Vice President of Regenerative Medicine at Mallinckrodt. "We are pleased to enroll the first patient in our Phase 1 ExpressGraft study."

About the Study
The Phase 1 study is titled "ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers." The study is designed as a prospective, open-label trial focused on assessing the safety and tolerability of ExpressGraft-C9T1 skin tissue in the treatment of DFU. Targeted enrollment for this study is up to six subjects with a confirmed diagnosis of diabetes and who have foot ulcers. Subjects will each receive a single application of ExpressGraft-C9T1 skin tissue on a single identified study DFU following a 10-14 day run-in period. Any subjects requiring additional treatment will receive protocol-defined dressings as necessary. Enrollment is staged with a minimum of one week between each subject.

The safety and tolerability of ExpressGraft-C9T1 skin tissue will be evaluated by monitoring adverse events, clinically significant vital signs, blood chemistry, safety laboratory values including but not limited to immunological testing, and incidence of treatment site infection through the 12-month study session.

Find more information about the trial here on the ClinicalTrials.gov website.

About Diabetic Foot Ulcers
More than 22 million people were diagnosed with diabetes in the U.S. in 2012 (7.7% of the population).¹ DFUs are open sores or wounds that occur on the foot in up to 25 percent of patients with diabetes during their lifetime^1,2 and are the cause of more hospitalizations than any other complication of diabetes.³  Diabetes is the leading cause of non-traumatic lower extremity amputations in the U.S. In patients with diabetes, complications of DFUs are considered the main cause of lower extremity amputations.^2,4  Foot ulceration precedes 85 percent of diabetes-related amputations.⁵  According to the American Podiatric Medical Association, 6 percent of patients with DFUs will be hospitalized for a complication related to the foot ulcer and approximately 14-24 percent of those will ultimately require amputation.⁶ 

About ExpressGraft-C9T1 Anti-Infective Tissue
ExpressGraft-C9T1 skin tissue builds on many of the same technologies pioneered in the development of StrataGraft, a skin substitute which is currently in Phase 3 for the treatment of severe burns. ExpressGraft-C9T1 is the first genetically engineered human skin substitute in development that expresses elevated levels of the human cathelicidin host defense peptide. Cathelicidin is a multifunctional human defense protein with broad-spectrum antimicrobial activity and is a mediator of wound healing through promotion of angiogenesis and epithelialization. ExpressGraft-C9T1 skin tissue and StrataGraft are both investigational products and are not approved by regulatory authorities. Safety and efficacy have not been established.

ABOUT MALLINCKRODT
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. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines and its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing. 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 ExpressGraft-C9T1 skin tissue and its ongoing clinical trial. 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; additional clinical trial results; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; future commercialization efforts; 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
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com

Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
daniel.speciale@mallinckrodt.com

Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mallinckrodt.com

Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mallinckrodt.com

¹ Economic Costs of Diabetes in the U.S. in 2012. Diabetes Care 36:1033–1046, 2013.
² Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005 Jan 12;293(2):217-28.
³ Frykberg RG, Zgonis T, Armstrong DG, et al. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. Sep-Oct 2006;45(5 Suppl):S1-66.
⁴ Consensus Development Conference on Diabetic Foot Wound Care: 7-8 April 1999, Boston, MA. American Diabetes Association. Diabetes Care. 1999 Aug; 22(8):1354-60.
⁵ Pecoraro RE, Reiber GE, Burgess EM. Pathways to diabetic limb amputation: basis for prevention. Diabetes Care 1990;13:513--21.
⁶https://www.apma.org/Patients/FootHealth.cfm?ItemNumber=981

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SOURCE Mallinckrodt plc