Final Clinical Study Report received for PulmoStem Phase Ib clinical trial
September 13, 2023
Amniotics AB (publ) (Nasdaq Stockholm: AMNI) today announces the company has received the finalized clinical study report for the Phase Ib clinical trial of the cell therapy product candidate PulmoStem which was evaluated in patients with severe lower airway infections caused by Covid-19, Influenza A, and RS-virus. The report confirms the previously announced positive topline results for safety and tolerability.
The primary objective of the study was to evaluate the safety and tolerability of intravenous dosing of PulmoStem in patients with severe lower respiratory tract infections such as Covid-19, influenza A, and RS virus. The study also included secondary and exploratory endpoints related to lung regeneration, biomarkers of inflammatory response, and other clinical endpoints. The study was an adaptive and dose-escalating study that included 6 hospitalized patients with Covid-19 or other lower respiratory tract infections and was conducted at a clinic in Sweden.
The company will, together with the physicians and researchers involved in the study, analyze the results and present the findings in a scientific journal.
-We are pleased to receive the final clinical study report. Study data analysis on how an inflammatory response in the lung can be modulated will help drive our future development of PulmoStem, says Marcus Larsson, CEO, Amniotics AB.