Mallinckrodt Announces Positive Top-line Results from Pivotal Phase 3 Clinical Trial of StrataGraft?Regenerative Tissue in Patients with Deep Partial-thickness Thermal Burns
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
- Study met both co-primary endpoints with high statistical significance, demonstrating autograft sparing and durable wound closure at three months with StrataGraft -
- Company plans to submit Biologics License Application to the U.S. Food and Drug Administration in the first half of 2020 -
STAINES-UPON-THAMES,?United Kingdom,?Sept. 23, 2019?/PRNewswire/ --?Mallinckrodt plc?(NYSE: MNK), a global biopharmaceutical company, today 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.
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," said?Dr.?James H. Holmes IV, study co-lead investigator and Director of?Wake Forest Baptist Medical Center's?Burn Center. "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."
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.
"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," said?Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at?Mallinckrodt.?"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."
Design and Results of Phase 3 Study (STRATA2016)
The pivotal open-label, controlled, randomized, multicenter Phase 3 trial in adults evaluated the efficacy and safety of a single application of StrataGraft tissue in the treatment of deep partial-thickness thermal burns. The study enrolled 71 study participants across 12 clinical sites in?the United States. Study participants were age 18 years and older and had 3-49% total body surface area complex skin defects caused by thermal burns that contained intact dermal elements for which surgical excision and autografts were clinically indicated. The study design used an intra-patient control, in which two similar areas of burn injury on the same study participant were randomly assigned to either standard of care (autograft) or StrataGraft treatment.
The co-primary endpoints included autograft sparing (the difference in the percent area of thermal burn wounds treated with StrataGraft tissue that required autografting compared with the control autograft treatment sites by three months), and durable wound closure (the proportion of study participants achieving durable wound closure of the StrataGraft-treated site at three months without autograft placement).
Key co-primary endpoints findings included the following:
- On average, 4% of the area of StrataGraft-treated sites required autografting by three months. By design, 100% of the area of control-treated sites was autografted and an additional 2% of the area required subsequent autografting by three months. This resulted in a 98% reduction in the area requiring autograft in the StrataGraft-treated sites compared to the control-treated sites (p<0.0001).
- 83% of burn wounds treated with StrataGraft tissue alone achieved durable wound closure at the treatment site at three months post-placement (95% confidence interval: 74.4-91.8%, meeting the pre-defined threshold of statistical significance). As a reference, 86% of the burn wounds treated with a single application of autograft achieved durable wound closure at three months post-placement (95% confidence interval: 77.8-94.0%).
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SOURCE?Mallinckrodt plc