Date: 2012-12-11
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the study
Company: Shire (UK-USA)
Product: ABH001
Action
mechanism: ABH001 is an engineered, human fibroblast-derived dermal substitute generated by culturing human neonatal dermal fibroblasts onto a bioresorbable polyglactin mesh scaffold. The PGLLA (poly(glycolide-co-L-lactide) mesh which serves as the scaffolding onto which fibroblasts are grown, they secrete dermal collagen, other extracellular matrix proteins, growth factors, and cytokines, creating a three-dimensional human tissue containing metabolically active living cells. The final product consists of a well-developed dermal matrix and evenly dispersed neonatal dermal fibroblasts.
ABH001 for EB has been granted an orphan drug designation in the US and EU, and has also received Fast Track designation from the FDA, which is aimed at facilitating the development and expediting the review of drugs and biologics that fill an unmet medical need. In addition, the European Medicines Agency’s Pediatric Committee has agreed on a pediatric investigation plan for ABH001 for the treatment of EB.
ABH001 is currently approved and marketed in the United States as a Class III medical device under the trade name Dermagraft® for the treatment of diabetic foot ulcers.
Disease: epidermolysis bullosa
Therapeutic area: Rare diseases - Genetic diseases - Dermatological diseases
Country: USA, Austria, Canada, France, Germany, Poland, Portugal, Spain
Trial
details: ThePhase 3 study is a multi-site, prospective, randomized, open-label, intra-subject controlled trial evaluating the efficacy and safety of ABH001 to initiate healing and reduce the wound surface area of selected stalled, chronic cutaneous wounds associated with generalized epidermolysis bullosa (EB). Approximately 20 subjects with generalized EB aged three years and older are planned to enroll in the trial, which is targeted to be conducted in 10 to 15 sites across the US, Europe and Canada. The study will comprise ABH001 applications sufficient to cover the surface area of the wound, applied topically every 4 weeks with protocol-specified dressings until healed or for up to 24 weeks. (NCT01749306)
Latest
news: The purpose of this study is to evaluate the efficacy and safety of ABH001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing. It is hypothesized that ABH001 may initiate and continue wound healing in patients with epidermolysis bullosa (EB).
Shire is also developing an intravenous protein replacement therapy for the treatment of dystrophic EB, which the company’s Human Genetic Therapies business recently acquired from Lotus Tissue Repair, Inc.
