Mallinckrodt's StrataGraft Tissue Phase III Data Positive
Zacks Investment Research | Sep 24, 2019 08:48AM ET
Beleaguered Mallinckrodt plc (NYSE:MNK) announced positive top-line results from a late-stage study on experimental StrataGraft regenerative tissue for the treatment of deep partial-thickness thermal burns.
The pivotal, open-label, controlled, randomized, multicenter phase III study in adults evaluated the efficacy and safety of a single application of StrataGraft tissue for the treatment of deep partial-thickness thermal burns.
The study used an intra-patient control, wherein two similar areas of burn injury on the same patient were randomly assigned to either standard of care (autograft) or StrataGraft treatment.
The study met both primary endpoints. Results showed that a significantly smaller area of burn wounds treated with StrataGraft tissue required autografting by three months as compared to treatment with only autograft. 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.
Results indicate that StrataGraft upon approval will provide an alternative treatment option to surgeons for deep partial-thickness burns. Moreover, the safety profile of StrataGraft tissue was comparable to that of autograft.
The encouraging results cheered investors. Mallinckrodt intends to submit a Biologics License Application for the same to the FDA in the first half of 2020.
Mallinckrodt’s shares have plunged 84.4% year to date compared with the Zacks Investment Research
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