Amniotics Phase Ib study of PulmoStem™ to include broader patient population
September 23, 2022
Amniotics AB (publ) (Nasdaq Stockholm: AMNI) today announced that the company has received approval from the regulatory authorities in the UK and Sweden for a protocol amendment to expand the clinical indications in its Phase Ib study of PulmoStem™ to also include patients with severe lower respiratory tract infections caused by other viruses than SARS-CoV-2 (COVID-19).
“We now are able to investigate the clinical potential of PulmoStem™ in a much wider range of difficult pathogens. Airborne viruses such as SARS-CoV-2 and Influenza A cause diseases with high morbidity and mortality, and new tools to combat such diseases are needed. This approval opens up a wider clinical spectrum in the continued development of PulmoStem™, to help patients with high clinical unmet needs,” says Marcus Larsson, CEO at Amniotics.
The study is conducted in the UK and Sweden and the clinical sites are activated and ready to start recruitment.
The Phase Ib clinical study is an adaptive, dose-escalation trial including 9-18 hospitalized patients. The primary objective is to evaluate the safety and tolerability of intravenous (IV) dosing of PulmoStem™ in patients with moderate to severe COVID-19 or other viral lower respiratory tract infections such as Influenza A, Metapneumovirus and Respiratory Syncytial Virus (RSV). The study will also include secondary and explorative endpoints related to lung regeneration indicators, biomarkers of inflammatory response and other clinical efficacy outcomes. Results from the study are expected in the second half of 2023. See clinicaltrials.gov (identifier: NCT05348772) for more details.