Amniotics announces first patient dosed in Phase Ib study with PulmoStem™ to treat severe viral lung disease
October 11, 2022
Amniotics AB (publ) (Nasdaq Stockholm: AMNI) today announced that the first patient has been dosed in its Phase Ib clinical study evaluating the lung-specific stem cell therapy PulmoStem™ in hospitalized patients with severe respiratory infections, including COVID-19, Influenza A, and other causes.
The primary objective of the study is to evaluate the safety and tolerability of intravenous (IV) dosing of PulmoStem™ in patients with severe lower respiratory tract infections, including COVID-19, Influenza A, Metapneumovirus and Respiratory Syncytial Virus (RSV). The study also includes secondary and explorative endpoints related to lung regeneration indicators, biomarkers of inflammatory response and other clinical efficacy outcome measures.
The study is an adaptive, dose-escalation trial including nine to eighteen hospitalized patients with COVID-19, which will be conducted across centers in Sweden and the UK. It is estimated to be completed in 2H 2023. See Clinicaltrials.gov (Identifier: NCT05348772) for more details.
“The initiation of this clinical trial is a major milestone for Amniotics. PulmoStem™ provides a novel approach for the treatment of severe and potentially fatal lung diseases, and our aim is to help patients that are in need of better treatments”, says Marcus Larsson, CEO at Amniotics