Mount Pleasant, S.C. – October 13, 2026 -- Paradigm Therapeutics, Inc. has been named a finalist for the 2026 Prix Galien USA "Best Start-Up" Award, its second consecutive nomination after being a nominee in 2025.
The clinical-stage biopharmaceutical company is developing SD-101 (ZorblesiaTM), a topical cream for wounds and lesions across the entire skin surface in patients with Epidermolysis Bullosa (EB). The Galien Foundation manages the awards, which will be presented on October 29, 2026, at the American Museum of Natural History in New York City.
SD-101 holds FDA Breakthrough Therapy status, a first for an EB treatment
SD-101 is the first EB treatment to receive U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation. It also carries FDA Rare Pediatric Disease and Orphan Drug designations, plus an earlier Orphan Drug designation from the European Commission. Paradigm will be eligible for a Priority Review Voucher (PRV) upon regulatory approval.
Phase II and III trials enrolled 217 patients across three EB subtypes
Completed Phase II and Phase III studies evaluated SD-101 in 217 pediatric and adult patients with Simplex, Dystrophic and Junctional EB. Patients applied the cream daily over the entire body for three months, including children as young as 28 days old. According to the company, the data point to broad benefit for lesions and wounds across the whole skin surface, with a favorable long-term safety profile.
The cream requires no special handling and can be stored at room temperature.
Paradigm runs a confirmatory pediatric study and courts partners for global rollout
A confirmatory two-month study is under way in pediatric patients aged 28 days to 12 years across all EB subtypes. CEO Robert Ryan said the company aims to complete development activities for SD-101 and move toward registration. Paradigm is working in parallel with potential partners to supply the therapy globally.
The company states that no approved therapies were developed to treat the entire skin surface of patients across all EB subtypes. Paradigm is privately held, and it cites dependence on third parties for development, regulatory approval and commercialization among its risk factors.