Mallinckrodt plc, a leading global biopharmaceutical company, announced today the release of the results of its Phase 1b clinical trial at StrataGraft®, examining regenerative tissue, c Burns, the journal of the International Burn Injury Society (ISBI). Study data indicate that single-stranded StrataGraft treatment resulted in wound closure for up to three months in 27 of 29 study participants. None of these 27 study participants required a donor skin harvest (autograph) until 28 days after administration. Furthermore, the observed wound characteristics treated with StrataGraft are comparable to those treated with autotransplantation at 12 months after treatment. The safety and efficacy of StrataGraft have not yet been established by the US Food and Drug Administration (FDA).
Over the last two to three decades, the survival rate among burn patients has increased, but there has been little progress in the treatment of severe burn wounds. New approaches are needed to minimize the challenges associated with auto-transplantation, the current standard of care. The results of StrataGraft's Phase 1b study are encouraging and suggest that this exploratory regenerative tissue may potentially reduce or eliminate the need for autotransplantation, which can minimize pain and other risks. "
Dr. James H. Holmes IV, Director of the Wake Forest Baptist Medical Center Burnout Center
An autograph is considered the standard of care for many for deep thermal burns of partial thickness, complex skin injuries where the burn extends into the lower dermis (skin below the surface of the outer layer of the skin), as well as the entire epidermis (outer layer of the skin) ). Because autotransplantation involves surgically harvesting healthy skin from a non-injurious site on the patient and transplanting the skin graft to the injury, patients have two wounds that require care. Not only do patients experience increased pain, but the burn site and the donor site are at increased risk of infection, scarring and impaired skin function.,
Based on the positive results of the efficacy and safety of the Phase 1b study, we have advanced the clinical development of StrataGraft tissue and have recently completed enrollment in a basic Phase 3 trial evaluating StrataGraft in adults with partial-thickness deep thermal burns. We appreciate the patients who participated in StrataGraft's clinical development program. If the Phase 3 core trial data is supportive, we plan to apply for a FDA license for organic products in 2020. We believe that StrataGraft, if approved, has the potential to revolutionize the treatment of patients with partial-thickness deep-burn and we we are committed to providing it to patients in need as quickly as possible. "
Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt
The data from the top line of the StrataGraft Phase 3 core sample is expected to be released in the next few months.
Design and results of a Phase 1b regenerative tissue study of StrataGraft
A prospective, randomized, controlled, open, multicenter, phase 1b dose escalation (STRATA2011) evaluates the safety, tolerability, and efficacy of single-use StrataGraft tissue versus auto-transplantation for the treatment of deep partial-thickness thermal burns. A total of 30 study participants between the ages of 18 and 65 years with deep thermal burns with a partial thickness of 3-49% total body surface area (TBSA) were treated with StrataGraft in three dose escalation cohorts of 10 patients each:
- Cohort 1: ≤220 cm2Refrigeration fabric StrataGraft
- Cohort 3: ≤440 cm2from StrataGraft cryopreserved fabric
- Cohort 3: ≤440 cm2from StrataGraft cryopreserved fabric
Two areas of deep burns with partial thickness of the upper or lower limbs or torso of each study participant were randomly assigned 1: 1 to receive StrataGraft or autograft treatment. The main endpoints of the study were the percentage area of StrataGraft healing site requiring autografting up to 28 days and closure of the wound (defined as ≥95% re-epithelialization with no drainage) at treatment sites three months after treatment. Secondary efficacy endpoints include the ratio of fully closed wounds at the treatment site, the percentage wound closure, the cosmetic (physical type) of the treatment and the donor sites and the pain at the donor site.
The main primary and secondary clinical findings include the following:
- Participants in the study reduced the percentage area autographed at the StrataGraft tissue treatment site relative to the autograph treatment site. By day 28, no StrataGraft-treated site requires automatic grafting.
- Within three months of treatment, 27 of 29 study participants (93%) of the intent-to-treat population achieved closure of the wound at the burn site treated with StrataGraft.
- Overall, the proportion of wounds at the site of treatment that achieved closure was not statistically different between StrataGraft and autograft treatment (p = 0.491).
- Score evaluation using the Patient and Observer Scale (POSAS) scale does not show significant differences between StrataGraft scores and autograft sites at any time, as assessed by clinical observers, or 12 months after treatment, as was evaluated by the study participants.
- StrataGraft-treated wounds do not require the collection of future donor sites, resulting in less reported pain.
The results of the Phase 1b study show that safety observations for StrataGraft tissue are comparable to those for an autograph. Itching (itching) is the most commonly reported adverse event (TEAE) observed in five of 30 study participants (17%); two out of five are probably related to exploratory treatment. All TEAEs associated with the study were mild or moderate in severity and were all permitted by the end of the study. Local infection is not observed at any of StrataGraft's treatment sites.