Mallinckrodt Announces Positive Top-line Results from Pivotal Phase 3 Clinical Trial of StrataGraft® Regenerative Tissue in Patients with Deep Partial-thickness Thermal Burns
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,
"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
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 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%).
The safety profile of StrataGraft tissue was comparable to that of autograft. Pruritus was the most commonly reported treatment-emergent adverse event (TEAE), occurring in 25 of 71 (35%) study participants treated with StrataGraft tissue (of which 11 of the 25 were possibly related to study treatment). All study treatment-related TEAEs were mild or moderate in severity. No local infections were related to StrataGraft treatment.
About StrataGraft Regenerative Tissue
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.
StrataGraft tissue is an investigational product, and its safety and effectiveness have not yet been established by the
Funding and technical support for the continued development of StrataGraft regenerative tissue, including the pivotal Phase 3 clinical study (STRATA2016) and the marketing approval registration process for StrataGraft tissue in
About Deep Partial-thickness Thermal Burns
Deep partial-thickness thermal 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).
Autograft is considered to be a standard of care by many for deep partial-thickness thermal burns. It involves the surgical harvesting of healthy skin tissue from an uninjured site on the patient and transplanting the skin graft to the injury. While this process can be effective in providing closure of the original wound, it has significant limitations related to the donor site wounds created during surgical removal of the skin tissue for grafting. Donor site wounds are extremely painful and can create risks of additional scarring and infection. In addition, the amount of healthy skin available for harvesting is frequently limited in those patients with large burns, necessitating sequential re-harvesting of available donor sites. As a result, there is an urgent need for alternatives to donor site harvesting for the treatment of severe burns.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements with regard to StrataGraft regenerative tissue, including expectations with regard to clinical data and regulatory filings, future research, 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: clinical trial results; 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
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1 https://www.gao.gov/assets/590/588738.pdf. Accessed
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