Israel-based MediWound has secured approval from the European Medicines Agency (EMA) regarding a Phase III trial investigating EscharEx in the treatment of venous leg ulcers (VLUs).
EscharEx is a topical bioactive therapy for debriding chronic and other hard-to-heal wounds.
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The Committee for Medicinal Products for Human Use (CHMP) within the EMA provided positive scientific advice on the development plan for the upcoming trial. The CHMP concurred with the overall trial design, including objectives, patient population, inclusion criteria, and chosen outcome measures.
MediWound plans to enrol 244 patients with VLUs in the global, randomised, placebo-controlled Phase III trial. The patients will be randomised either to EscharEx or gel vehicle cohorts in a 1:1 ratio.
The treatment protocol includes daily visits for up to 14 days, with treatment or placebo application once a day for a maximum of eight applications. All patients will also receive standard of care and be followed for up to ten weeks after treatment. Subjects who achieved wound closure confirmation will be observed for additional ten weeks.
The co-primary endpoints will measure the incidence of complete debridement at the end of the daily visit period and the time to achieve wound closure.
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By GlobalDataAccording to a company’s presentation in May, MediWound expects to initiate the Phase III trial in Q4 2023. MediWound also noted that the trial protocol aligns with the feedback from the FDA.
Required data for approval
The CHMP also provided feedback on the required data for the subsequent potential marketing authorisation submission and commercialisation.
The CHMP indicated that it can accept one confirmatory study in VLU patients as the basis for approval, assuming that the data are robust and similar to MediWound’s previous studies. The company has already conducted three Phase II clinical trials with EscharEx. The drug has so far been well-tolerated and demonstrated safety and efficacy.
EscharEx uses the same active pharmaceutical ingredient (API) as MediWound’s first approved drug NexoBrid, which was approved for the debridement of thermal burns in Europe in 2012 and received a US Food and Drug Administration (FDA) approval late last year.
The biologics licence application (BLA) and FDA approval were backed by a large set of pre-clinical studies and eight clinical trials. This included MediWound’s Phase III trial, which evaluated the safety and efficacy of NexoBrid in patients with deep partial-thickness and full-thickness thermal burns.
The company first reported positive topline data in January 2019.
