Second interim analysis of clinical outcomes results in recommendation to continue remestemcel-L phase 3 trial in patients with moderate to severe acute respiratory distress syndrome due to COVID-19

Analysis was performed on trial’s first 135 patients, 45% of target of up to 300 randomised patients, with Data Safety Monitoring Board recommending continuation after reviewing trial’s primary endpoint, all-cause mortality within 30 days of randomisation and all safety data.

SPS commentary:

Remestemcel-L is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from bone marrow of an unrelated donor. It is thought to have immunomodulatory properties to counteract the cytokine storms implicated in various inflammatory conditions by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

Biospace Inc.