Shire commences phase III epidermolysis bullosa drug trial

Shire has initiated a phase III trial of ABH001, a dermal substitute therapy for the treatment of non-healing wounds in patients with epidermolysis bullosa (EB).

The study will be a multisite, prospective, randomised, open-label, intra-subject controlled trial assessing the safety and efficacy of the drug in initiating healing and reducing wound surface area of selected stalled, chronic cutaneous wounds associated with generalised EB.

Around 20 subjects will be enrolled at ten to 15 sites across the EU, US and Canada, with results helping to build on the clinical profile of ABH001, which is marketed in the US under the name Dermagraft.

EB is the designation given to a group of rare genetic skin disorders that begin to manifest at birth or early childhood, for which there are currently very few available therapy options.

Dr Jeff Jonas, president of Shire Regenerative Medicine, said: "We are very eager to begin evaluating ABH001 as a potential wound treatment option for people with EB. We believe it has the potential to initiate and continue wound healing in this patient population."

Last month, the company announced the acquisition of Lotus Tissue Repair, a privately held biotechnology firm that is developing a protein replacement therapy for dystrophic EB.