Amniotics submits CTA for Phase I/II trial in COVID-19 patients with PulmoStem™


December 28, 2021

Amniotics AB (publ) (Nasdaq Stockholm: AMNI), a developer of novel cell therapy products, today announced that it has submitted a CTA (Clinical Trial Application) to relevant regulatory authorities in Europe to start a Phase I/II study of its lung-specific candidate drug PulmoStem™ in hospitalized COVID-19 patients.

Amniotics has filed its Clinical Trial Application (CTA) for its planned Phase I/II study with its lead candidate drug in lung specific mesenchymal stem cells PulmoStem™. It is the first clinical trial in humans with the primary aim of demonstrating that the candidate drug is safe and well tolerated. In addition, the planned study may provide an indication of the effectiveness in patient populations with relevant lung diseases and opens for investigations of PulmoStem™ in other respiratory indications pursued by Amniotics. Pending the COVID-19 situation, an approval to initiate the patient recruitment and dosing is expected sometime during H1 2022.
“We are working intensively at Amniotics with the preparations for our first clinical trial in COVID-19 patients and I’m pleased that we have submitted this application to the regulatory authorities. Due to the ongoing development of the pandemic, with new variants and increasing infection numbers, we find it important to consider alternative treatments that are not focused on antiviral drugs, such as stem cell therapies. But, at the same time, the development of the pandemic can prolong regulatory interactions and the ability for clinical sites to conduct clinical studies including recruitment of patients,” says Amniotics’ CEO Kåre Engkilde.


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