StrataGraft is under clinical development by Mallinckrodt and currently in Phase III for Burns. According to GlobalData, Phase III drugs for Burns have a 67% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how StrataGraft’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
StrataGraft overview
Startagraft (Allogeneic cultured keratinocytes and dermal fibroblast in murine collgen-dsat) is a allogeneic cellularized scaffold product. It is formulated as rectangular sheet for topical application. Stratgraft is indicated for the treatment of adults with thermal burns containing intact dermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns).
Startagraft is under development for the treatment of deep partial thickness thermal burns. It is a viable, full-thickness skin substitute designed to mimic natural human skin, with both dermal and fully differentiated epidermal layers. It is developed based on unmodified NIKS cells grown under standard operating procedures.
Stratagraft skin tissue was also under development for the treatment of epidermolysis bullosa and scleroderma digital ulcers
Mallinckrodt overview
Mallinckrodt develops, produces, markets, and distributes specialty pharmaceutical products and therapies. The company offers branded pharmaceutical products for autoimmune and rare diseases in specialty areas such as rheumatology, nephrology, neurology, pulmonology and ophthalmology. It also offers immunotherapy, oncology and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. It offers specialty generic drugs and active pharmaceutical ingredients. Mallinckrodt markets branded products directly to physicians, specialty pharmacies, hospitals and ambulatory surgical centers; and also distributes branded and generic products through a network of drug distributors, specialty pharmaceutical distributors, and retail pharmacy chains, among others. It has facilities in the US, Ireland, Japan, and other countries. Mallinckrodt is headquartered in Dublin, Ireland.
For a complete picture of StrataGraft’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
