MediWound ($MDWD) announced that it has been granted that it has received endorsement from The European Medicines Agency for expanding the patient population in Phase 3 Children Innovative Debridement Study (CIDS) to include burn patients at least one year old instead of four years old. The recommendation was made by the Data Safety Monitoring Board after it reviewed blinded data from the study.
NexoBrid is the company's proprietary pharmaceutical product for the enzymatic removal of eschar (dead skin) in patients with deep-partial and full-thickness thermal burns. The study objectives are to evaluate the efficacy and safety of treatment with NexoBrid compared with standard of care (SOC) in hospitalized children with severe thermal burns of 1% to 30% total body surface area.
MediWound also recently reported data from the follow-up period of six months from last treatment or three months from wound closure for EscharEx Phase 2 clinical trial. The study met its statistically-powered primary endpoint, the incidence of complete debridement at the end of the debridement period.
The company stock has performed well this year so far as the price soar over 30% on Year to Date basis. Following recent spate of positive news for various company products, it is expected that the stock will retain its upward momentum.