US-based clinical-stage pharmaceutical firm Scioderm has started a Phase IIB trial of its novel topical therapy ‘SD-101’ for the treatment of non-healing wounds in patients with epidermolysis bullosa (EB).
EB is a rare, genetic connective tissue disorder that typically manifests at birth or early childhood and for which currently there is no cure or effective treatment.
The company has already secured orphan drug designation from the US FDA for SD-101 for the treatment of EB. In December 2013, it received a positive opinion by the Committee for Orphan Medicinal Products (COMP) in the EU.
In addition, the company is claimed to be the first to receive FDA breakthrough therapy designation for SD-101 for the treatment of skin effects in patients with EB.
Scioderm president and chief executive officer Robert Ryan said people affected by EB suffer skin blisters, chronic wounds endure almost constant pain and itching, and scarring.
"The current standard of care is palliative only and focuses primarily on daily wound care, bandaging and pain management," Ryan said.
"We believe SD-101 has the potential to initiate and continue healing of lesions in this patient population, and Scioderm is committed to develop SD-101 as expeditiously as possible as a treatment option for patients suffering from this devastating condition."
The multi-site, prospective, randomised, placebo-controlled Phase IIB trial is designed to evaluate the efficacy and safety of SD-101 to close selected chronic cutaneous wounds and reduction in body surface area (BSA) coverage of lesional areas on the skin in patients with EB as well as it will help in assessing the improvement on pain and itching.
A total of 48 subjects aged six months and older are expected to be enrolled in the trial, which is being carried out in seven sites across the US.
The trial will include application of SD-101 cream over the entire body daily for a period of three months.
The company said that patients completing the trial will be eligible to continue receiving SD-101 once the study is completed.