Mallinckrodt plc today announced enrollment of the first patient in StrataSOMA, a Phase 1/2a clinical trial that is assessing StrataGraft.
-- Company pursuing additional indication for FDA-approved product as part of clinical development program -- |
| [16-December-2021] |
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DUBLIN, Dec. 16, 2021 /PRNewswire/ -- Mallinckrodt Pharmaceuticals plc (OTCMKTS:MNKKQ), a global biopharmaceutical company, today announced enrollment of the first patient in StrataSOMA, a Phase 1/2a clinical trial that is assessing StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat) for the investigational treatment of adults with third-degree full-thickness thermal burns.
In June 2021, the U.S. Food and Drug Administration (FDA) approved StrataGraft for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns). Development of StrataGraft has been funded in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201500027C. The StrataSOMA trial is not BARDA-supported. Please see Important Safety Information below. "As we launch StrataGraft commercially, we are continuing our clinical development activities, which includes the StrataSOMA clinical trial, with the goal of seeking to expand the approved indication to include other patient populations with severe burns," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "For patients with full-thickness thermal burns, treatment options that may help reduce the amount of skin required for autografting are needed to help clinicians improve care and treatment management." Each year, approximately 40,000 patients in the United States require hospitalization for the treatment of severe burns.1 Third-degree full-thickness burns – skin injuries that destroy the epidermis (outermost layer of skin) and dermis (innermost layer of skin) – are treated with autografting.2 This involves the surgical harvesting of healthy skin from an uninjured site on the patient and transplanting the skin graft to the injury, creating a donor site wound and leaving the patient with more wounded areas requiring care.2 About the StrataSOMA Clinical Trial Additional study details can be found at clinicaltrials.gov (NCT04765202). About StrataGraft The FDA granted StrataGraft orphan drug designation, and it was among the first products designated by the Agency as a Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act. At the time of approval, the FDA awarded Stratatech Corporation, a Mallinckrodt company, a Priority Review Voucher (PRV). INDICATION IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Adverse Reactions
Pediatric Use
Please see full Prescribing Information. About Mallinckrodt 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 StrataGraft, including clinical trial plans and potential outcomes, 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 Media Inquiries Investor Relations 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. ©2021 Mallinckrodt. US-2101473 12/21 1 American Burn Association. Burn Incidence Fact Sheet. http://ameriburn.org/who-we-are/media/burn-incidence-fact-sheet/. Accessed November 24, 2021.
SOURCE Mallinckrodt plc |
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Company Codes: OTC-PINK:MNKKQ |
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