Zorblisa™ is Paradigm’s investigational topical therapy being developed for treating whole body skin lesions (blisters, tears, sores) associated with all subtypes of Epidermolysis Bullosa (EB).
Zorblisa™ Is the only topical, whole body treatment in development for treatment of the skin effects of EB in patients across all major EB subtypes ranging in age from 1 month and older.
Multiple clinical trials (Phase 2a, 2b and 3) have been conducted at multiple sites in the U.S. and Europe to evaluate the safety and efficacy of Zorblisa™ in patients with various subtypes of EB (Simplex, Recessive Dystrophic and Junctional [non-Herlitz]). Clinical studies have demonstrated improvements in wound healing along with an excellent long term safety profile in patients to date.
Data from an early study in EB demonstrated that Zorblisa™ was effective in treating lesions in EB patients, and based on that promising clinical data, Zorblisa™ was awarded “Breakthrough Therapy Designation by the FDA”.
In addition, Zorblisa™ has also received the following designations for the treatment of the skin manifestations across EB subtypes:
Rare Pediatric Disease designation by the FDA
Orphan Drug Designation from US and European Authorities
The active moiety in Zorblisa™ has a multifaceted pharmacological action on the skin, wound environment and wound healing process, including the following:
Accelerates wound healing by promoting formation of epithelial and granulation tissue
Bacteriostatic, bactericidal, and effective in removing necrotic tissue
Keratolytic effects
Anti-inflammatory effects
For information regarding the development of Zorblisa™ (SD-101):
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