Second Interim Analysis of Clinical Outcomes After 135 Patients Results in Recommendation to Continue Remestemcel-L Phase 3 Trial in COVID-19 ARDS - Seite 2

Mesoblast holds an Investigational New Drug (IND) submission for remestemcel-L in COVID-19 ARDS, with trial size, protocol design, and endpoints developed with input from the United States Food and Drug Administration. The third and final interim analysis, when 60% of the randomized target has completed 30 days of follow-up, will occur in the coming weeks.

References

1. Mortality of COVID-19 Admitted Patients on Mechanical Ventilators. Epic Health Research Network. June 26, 2020
2. Harrison SL., et al. Comorbidities associated with mortality in 31,461 adults with COVID-19 in the United States: A federated electronic medical record analysis. PLOS Medicine. September 10, 2020. https://doi.org/10.1371/journal.pmed.1003321
3. Sanyaolu A., et al. Comorbidity and its Impact on Patients with COVID-19. SN Compr Clin Med. 2020 Jun 25: 1-8. doi: 10.1007/s42399-020-00363-4
4. Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report. New England Journel of Medicine. July 17, 2020. DOI: 10.1056/NEJMoa2021436
5. Tomazini BM., et.al. Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19. JAMA 2020;324(13):1307-1316.

About Remestemcel-L
Mesoblast’s lead product candidate, remestemcel-L, is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is thought to have immunomodulatory properties to counteract the cytokine storms that are 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.

About Mesoblast
Mesoblast Limited (Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.