We are proud to announce that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation to our investigational drug, Udonitrectag lysine, for the treatment of diabetic foot ulcers (DFU).
Existing measures for the treatment of diabetic foot ulcers achieve complete healing in only 30–60% of cases within six months, with 40% one-year recurrence and amputation rates around 20–30% in complicated ulcers. This represents a significant unmet medical need for innovative medicines capable of providing a clinically meaningful and durable improvement in healing and limb salvage.
Evidence from a 6-week, randomised, single-blind, comparative Phase 1/2 study in 24 patients with slow-healing diabetic foot ulcers testing Udonitrectag lysine in addition to standard of care versus standard of care alone suggests that a potentially clinically meaningful treatment effect addressing this unmet medical need can be achieved.
PRIME is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary programme is based on enhanced interaction and early dialogue with developers of promising medicines to optimise development plans and accelerate evaluation, helping these medicines reach patients earlier.
“Receiving PRIME designation is an important recognition of the potential of Udonitrectag lysine to make a real difference for patients affected by diabetic foot ulcers,” said Federico Cozzolino, CEO of MimeTech S.r.l. “We look forward to working closely with EMA to advance the development of this innovative therapy and to bring it as soon as possible to patients in need.”