Pluristem Therapeutics Inc. (NASDAQ: PSTI) has released topline findings from phase 2 dose-escalation trials evaluating the efficacy and safety of intramuscular PLX-PAD cells injection for injection COVID-19 related acute respiratory syndrome treatment. The analysis of the findings was from a collection of 89 patients enrolled in two second-phase studies.
The primary efficacy endpoint was the number of ventilator-free days
The primary effectiveness objective was the number of ventilator-free days (VFD) from the first day to day 28 of the studies. The Studies’ secondary efficacy objectives included VFD at day 60 and all-cause mortality at days 28 and 60. The studies did not meet the primary effectiveness goal of statistically significant improvement in VFD at 28 days. There were no changes in the safety profile between PLX-PAD and placebo when the baseline risk factors of the ARDS patients were taken into account.
Pluristem said in July 2021 that it had decided to bring the Studies to an early clinical readout based on 89 patients recruited, rather than the 180 patients initially envisaged (140 in the United States study and 40 in the EU study). The company made the decision in reaction to COVID-19’s progression as a disease with the significant changes in standard of care, which resulted in an increase in the severity of intubated patients’ situations. As a result, the potential variability in the participants in the studies was raised due to these alterations in COVID-19’s evolution. In addition, the Studies’ statistical power was significantly reduced due to the early termination of recruiting.
Pluristem part of global effort to fight COVID-19
The company’s CEO and President Yaky Yanay stated, “Pluristem joined the global effort to fight the evolving and unexpected COVID-19 pandemic. We chose to focus on the most severe intubated patients suffering from ARDS associated with COVID-19, that have no viable treatment to date and are challenging healthcare systems worldwide. With the new coming wave of the Omicron variant, we intend to explore the opportunities based on the efficacy trends obtained from the Studies. I would like to thank everyone who has been involved in the Studies.”
