Mallinckrodt plc, a global biopharmaceutical company, has announced positive top-line results from its pivotal Phase 3 clinical trial of its investigational StrataGraft® regenerative tissue. The study, which met both primary endpoints, evaluated the efficacy and safety of a single application of StrataGraft in the treatment of deep partial-thickness thermal burns. Each study participant served as his or her own control.
Founded in 1867 at St. Louis, Missouri, Mallinckrodt is a global business now headquartered in Staines-upon-Thames, UK, 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.
Autograft is considered to be a standard of care by many for deep partial-thickness thermal burns. Such burns are complex skin injuries in which the damage extends through the entire epidermis (outermost layer of skin) and into the lower part of the dermis (innermost layer of skin). As autograft involves the surgical harvesting of healthy skin from an uninjured site on the patient and transplanting the skin graft to the injury, patients are left with two wounds requiring care. Patients who receive an autograft may experience pain, itching, scarring and impaired function at the donor site.
StrataGraft regenerative tissue is an investigational treatment being developed to reduce or eliminate autograft in patients with severe thermal burns. An engineered, bilayer tissue, StrataGraft is designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers. StrataGraft can be sutured, stapled or secured with an adhesive. StrataGraft tissue is cryopreserved in order to deliver viable cells upon application.
Results showed that a significantly smaller area of burn wounds treated with StrataGraft tissue required autografting by three months compared to the area of burn wounds treated exclusively with autograft (p<0.0001). Additionally, results showed that the proportion of StrataGraft-treated wounds that achieved durable wound closure at three months exceeded the pre-defined threshold for statistical significance.
Based on the positive Phase 3 data, Mallinckrodt plans to submit a Biologics License Application for StrataGraft tissue to the FDA in the first half of 2020. StrataGraft tissue is an investigational product, and its safety and effectiveness have not yet been established by the U.S. Food and Drug Administration (FDA).
“Treatment advances are needed that can help minimize or eliminate the need to harvest skin tissue for autografting, as the second wound created by removing healthy skin can be associated with complications and can be even more painful than the burn wound itself.” … “The positive top-line results of the Phase 3 trial suggest that this investigational regenerative tissue, if approved, could provide burn surgeons with an alternative treatment option for deep partial-thickness burns.” – Dr. James H. Holmes IV, study co-lead investigator and Director of Wake Forest Baptist Medical Center’s Burn Center
“Achieving the co-primary endpoints in our pivotal Phase 3 trial and exceeding statistical thresholds for both endpoints represents an important development milestone for StrataGraft tissue, which has the potential to help patients suffering from deep partial-thickness thermal burns. Coupled with the recently announced positive Phase 3 results for terlipressin in hepatorenal syndrome, or HRS, type 1, these Phase 3 results demonstrate our ability to design and execute successful development programs targeting complicated, serious conditions.” … “We are committed to providing StrataGraft to patients in need as a potential paradigm-changing treatment and alternative to autograft, if approved. We would like to thank the study participants and investigators in the Phase 3 clinical trial and all of the others who have helped us advance the clinical development program for this investigational product.” – Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt