Paradigm Therapeutics, a clinical-stage biopharmaceutical company focused on developing innovative treatments for rare diseases, has announced that the first patient has been enrolled in its phase 3 clinical trial evaluating Zorblesia, an investigational topical cream for the treatment of chronic wounds and skin lesions associated with epidermolysis bullosa (EB).
EB is a rare genetic disorder characterised by fragile skin that blisters and tears easily, often beginning at birth or during early childhood. The condition can cause chronic wounds, pain, itching, infections, and scarring, placing a substantial burden on patients and their families.
The SD-007 study is a multicentre, prospective, randomised, double blind, placebo-controlled trial designed to evaluate the efficacy and safety of SD-101 in patients with EB simplex (EBS), recessive dystrophic EB (RDEB), and junctional EB (JEB).
The study will assess the closure of selected chronic target wounds, changes in the body surface area affected by wounds and lesions, and improvements in itching.
Approximately 80 patients aged 28 days to 12 years old are planned for enrolment at 17 clinical sites across 14 countries, spanning North America, South America, Europe, Asia and Australia.
Participants will apply SD-101 cream or the study comparator daily over the entire body for two months, according to the study protocol.
