Amniotics AB (publ) 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 second quarter of 2023. PulmoStem is a lung-specific stem cell product, derived from full-term amniotic fluid.

PulmoStem is expected to be efficacious in various acute and chronic diseases of the lung through modulation of the immune response and anti-fibrotic capabilities. The first-in-human clinical study with PulmoStem, is targeting hospitalized patients suffering from severe lower respiratory tract infections due to COVID-19, Influenza A, Metapneumovirus, Respiratory Syncytial Virus (RSV) and other causes, which can lead to Acute Respiratory Distress Syndrome (ARDS). PulmoStem is also being investigated for lung transplantation treatment and chronic lung-disease e.g. Idiopathic Pulmonary Fibrosis (IPF).