Pharmaceutical company Citius Pharmaceuticals Inc (Nasdaq:CTXR) said on Friday that it has received a written response from the US Food and Drug Administration (FDA) for its pre-investigational new drug (PIND) application for its induced mesenchymal stem cells (iMSCs) to treat and reduce the severity of acute respiratory distress syndrome (ARDS) in patients with COVID-19.

Under under the FDA's Coronavirus Treatment Acceleration Programme (CTAP), the company said it can apply for the fast track designation as well as receive the the chemistry, manufacturing and control (CMC) requirements for the proposed trials. It plans to initiate actions on the the recommendations and follow up with an Investigational New Drug (IND) application.

The company added that the mesenchymal stem cell therapy product is derived from a human induced pluripotent stem cell (iPSC) line generated using a proprietary mRNA-based (non-viral) reprogramming process. The iMSCs secrete immunomodulatory proteins that may reduce or prevent pulmonary symptoms associated with ARDS in patients with COVID-19. ARDS is a rapidly progressive lung disease that occurs in critically ill patients – most notably now in those diagnosed with COVID-19.