Mediwound win fails to provide a boost

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Last month investors punished Mediwound for getting a complete response letter for its lead project, Nexobrid, and a pivotal trial win today has not managed to make amends. The Israeli group opened up 7% this morning on the back of topline data from a study of Nexobrid in children with severe burns, but questions remain around whether Nexobrid will be approved by the FDA, and the shares later traded down. Perhaps the most worrying aspect of the CRL involved “observations” made during good clinical practice inspections related to Mediwound’s pivotal Detect trial in adults – it is unclear yet whether these affected the findings of that study. There are also separate questions about the commercial prospects of Nexobrid, which was approved in Europe in 2012 but has seen slow adoption. Mediwound reported product sales of $7.8m in 2020, but much of this was down to emergency stockpiling by Barda. Evaluate Pharma estimates that Nexobrid, which is licensed to Vericel in North America, will bring in $50m by 2026. Even if the project does eventually gain FDA approval this could be a long shot, and the new data in children will do little to change this.

Nexobrid in children: results from the CIDS study (NCT02278718)
Endpoint Nexobrid group SOC group P value
Time to complete eschar removal* 0.99 days 5.99 days 0.0008
% wound area surgically excised for eschar removal* 1.5% 48.1% <0.0001
Quality of scars (non-inferiority analysis)* Values not given: "Nexobrid non-inferior to SOC" <0.0001
Incidence of surgical excision for eschar removal 8.3% 64.4% <0.0001
Blood loss during eschar removal procedure 32.4ml 202.6ml 0.134
Incidence of autograft performed in DPT wounds 25.9% 37.6% 0.05
% area of DPT wound autografted 15.9% 22.8% 0.5
Time to complete wound closure (non-inferiority analysis) 32 days 34 days 0.0149
*Co-primary endpoint; DPT=deep partial thickness; Eschar=dead tissue surrounding burns. Source: company release.

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