Treatment is a lung-specific stem cell therapy designed for hospitalised patients with respiratory infections.
Amniotics AB has announced that safety criteria have been met in the second cohort of its concluded phase 1b clinical trial investigating PulmoStem.
The treatment is a lung-specific stem cell therapy designed for hospitalised patients with severe respiratory infections triggered by COVID-19, influenza A, Metapneumovirus and respiratory syncytial virus (RSV). These diseases, if left untreated, can lead to acute respiratory distress syndrome.
The central aim of the study – which was conducted in Sweden – was to evaluate the tolerability and safety of intravenous dosing when incorporating PulmoStem. The trial also included secondary and exploratory endpoints related to biomarkers of the inflammatory response, lung regeneration and other clinical endpoints.
PulmoStem is derived from full-term amniotic fluid and is expected to be effective in various chronic and acute lung conditions through modulation of the immune response and anti-fibrotic capabilities.
The dose escalation committee has subsequently announced that no dose-limiting safety findings emerged during the second dose level of two million cells per kilogram of body mass. Amniotics has also previously revealed that the research ended after the second dose level and that the study report is expected to be released later in 2023.
Marcus Larsson, chief executive officer at Amniotics, is confident that the product can make a difference: “An exciting and at the same time expected result. That the dose escalation committee’s review shows safety at the dose of two million cells per kilogram is positive for the continued development of PulmoStem and we are now looking forward to the data from the final report.”
Meanwhile, PulmoStem is being investigated for lung transplantation treatment and chronic lung disease, including idiopathic pulmonary fibrosis.