Amniotics – January to March in brief

Claus Thestrup

Claus Thestrup

CEO, HCA Capital Sweden

Amniotics received a grant of SEK 4,8 million from Sweden’s Innovation Agency, Vinnova, together with Professor Sandra Lindstedt at Skåne University Hospital. The grant will be used to demonstrate proof of concept of using Amniotics stem cell therapy to repair damaged discarded donor lungs for transplantation and for reducing the incidence of unwanted side-effects after lung transplantations. Amniotics’ stem cell therapy product PulmoStem is expected to stop the inflammatory process and facilitate regeneration of damaged lung tissue, regardless of cause. It therefore has the potential to be useful in a variety of different respiratory indications.

Amniotics’ planned Phase I/II study in hospitalized COVID-19 patients is a first-in-human clinical trial to investigate the safety and tolerability of intravenous (IV) dosing at different doses of PulmoStem in patients with moderate to severe COVID-19. The study was approved by the regulatory authorities in the UK and Sweden in early April. In all, 9-18 hospitalized patients will be included in the study, which will also have secondary and exploratory endpoints related to lung regeneration effects, inflammatory response biomarkers and other clinical efficacy outcomes.

“Amniotics’ vision is to develop life-changing treatments and we are convinced that our unique drug candidate PulmoStem has the potential to improve life for people who suffer from serious pulmonary diseases. We are now extremely close to the next important milestone for Amniotics — starting the first clinical trial with a focus on COVID-19/ARDS.” says Kåre Engkilde, CEO of Amniotics.

Amniotics is a biopharmaceutical company focusing on mesenchymal stem cells (MSCs) from amniotic fluid. The company was born out of the discovery of a new source of stem cells in full- fledged amniotic fluid. Based on a decade of research at the internationally recognized Lund University Stem Cell Center and Skåne University Hospital in Lund, the company is a pioneer in harvesting and propagating tissue-specific mesenchymal stem cells of neonatal quality (MSC). Amniotics is now entering clinical trials with the leading drug candidate, PulmoStem, and wants to establish strategic partnerships with researchers and companies interested in developing stem cell- based therapies focused on diseases with highly fulfilled needs.