Amniotics Phase I/II study of PulmoStem™ in hospitalized COVID-19 patients ready to start
August 22, 2022
Amniotics AB (publ) (Nasdaq Stockholm: AMNI) today announced that several batches of PulmoStem™ have been certified by the company’s Qualified Person (QP) and that clinical sites in the UK and Sweden are set to start the enrollment of subjects in the first-in-human Phase I/II study of hospitalized COVID-19 patients.
“During the summer we have worked intensely on completing the preparations at the trial sites and preparing for the release of PulmoStem™ for our first clinical trial. We are therefore very pleased to announce that Amniotics’ QP has released several batches of PulmoStem™ to the clinical sites, which means that we are set for the start of the trial. We expect to have the first patients enrolled shortly and to be able to present results from the study in the second half of 2023,” says Kåre Engkilde, CEO at Amniotics.
The study is an adaptive, dose-escalation trial including 9-18 hospitalized patients with COVID-19. The primary objective is to evaluate the safety and tolerability of intravenous (IV) dosing of PulmoStem™ in patients with moderate to severe COVID-19. The study will also include secondary and explorative endpoints related to lung regeneration indicators, biomarkers of inflammatory response and other clinical efficacy outcomes. See Clinicaltrials.gov (Identifier: NCT05348772) for more details.
The study has previously been approved by the regulatory authorities in the UK, the Medicines & Healthcare products Regulatory Agency (MHRA) and in Sweden, the Medical Products Agency (MPA).