Pluristem misses endpoint in Phase 2 ARDS-Covid trial

 Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI) (the “Company”), a leading biotechnology company, today announced topline results from its Phase II dose escalation studies evaluating the safety and efficacy of intramuscular injections of PLX-PAD cells for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. The analysis is based on 89 patients enrolled in two Phase II studies in the U.S. (the “U.S. study”) and in Europe and Israel (collectively, the “EU study” and together with the U.S. study, the “Studies”).

The primary efficacy endpoint was the number of ventilator free days (VFD) from day 1 through day 28 of the Studies. VFD at day 60 and all-cause mortality at days 28 and 60 were part of the secondary efficacy endpoints in the Studies. The Studies did not meet the primary efficacy endpoint of statistically significant improvement of VFD at 28 days. Taking into consideration the baseline risk factors of the ARDS patients, no differences in the safety profile were observed between PLX-PAD and placebo.

https://finance.yahoo.com/news/pluristem-reports-topline-results-phase-120000676.html