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Study of novel topical therapy for epidermolysis bullosa initiated
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Scioderm announced a phase 2b study on the efficacy and safety of its novel topical therapy for treating nonhealing wounds in patients with epidermolysis bullosa has begun.
The prospective, placebo-controlled trial will evaluate SD-101, a topical cream that has demonstrated potential improvement in patients with epidermolysis bullosa (EB), a rare, genetic connective tissue disorder that manifests at birth or early childhood, according to a press release. The study will examine SD-101’s ability to close patients’ chronic cutaneous wounds and reduce body surface area coverage of lesions (simplex, recessive dystrophic or junctional).
Plans call for approximately 48 patients, aged 6 months and older, to enroll in the study at seven US sites and also will examine improvement of pain and itching. Patients will apply SD-101 cream over their entire body for 3 months. Those who complete the study will eligible to continue treatment.
Amy Paller
“We look forward to testing this new potential intervention in the double blind, randomized trial,” Amy Paller, MD, chair of the department of dermatology, Northwestern University Feinberg School of Medicine, said in the release. “If the lives of the EB patients are improved with topical use of SD-101 through faster wound healing, as well as decreased pain and itchiness, this cream would be welcomed by our affected families.”
SD-101 received FDA orphan drug designation for treating EB and a positive opinion by the Committee for Orphan Medicinal Products in Europe. The FDA also issued SD-101 breakthrough therapy designation last year for treating skin effects of patients with EB, which conveys fast-track program features and intensive FDA guidance on drug development.
“The current standard of care is palliative only and focuses primarily on daily wound care, bandaging and pain management,” Robert Ryan, PhD, president and chief executive officer of Scioderm, said in the release. “We believe SD-101 has the potential to initiate and continue healing of lesions in this patient population.”