Paradigm Therapeutics discovered novel SD-101, a topical whole-body treatment for all subtypes of Epidermolysis Bullosa (EB).
Epidermolysis Bullosa stands as a profoundly devastating genetic disorder, characterised by skin that is exceedingly fragile and prone to severe blistering and chronic wounds that often emerge shortly after birth. The urgent requirement for innovative treatment options to address the debilitating skin manifestations in Epidermolysis Bullosa (EB) patients is evident.
The introduction of SD-101, if proven effective and granted regulatory approval, can represent a significant breakthrough in ameliorating the considerable burden placed on individuals grappling with EB and substantially improving their quality of life.
Remarkably, the results from the comprehensive Phase II and Phase III trials indicate that SD-101 holds promise as a viable therapeutic candidate for addressing the lesions and skin wounds that afflict paediatric and adult EB patients who currently lack viable whole-body treatment alternatives. An encouraging facet of these trials is the demonstration of SD-101's favourable safety profile, reinforcing its potential as a practical and well-tolerated solution.
Epidermolysis Bullosa affects a substantial number of children and adults throughout their lifespans, yet approved therapies to comprehensively treat the entirety of the body remain nonexistent. Currently, the primary standard of care centres around pain management, wound cleansing, and meticulous bandaging of open wounds to mitigate the risk of infection.
SD-101 stands out as the first EB treatment to attain the FDA Breakthrough Therapy designation..