FDA Approves BioCardia's Phase 1 Trial With Cell Therapy In COVID-19, Shares Jump

  • The FDA has signed off BioCardia Inc's BCDA Investigational New Drug (IND) application for BCDA-04 to initiate Phase 1/2 trial in adult patients recovering from Acute Respiratory Distress Syndrome (ARDS) due to COVID-19.
  • BCDA-04 is a proprietary allogeneic mesenchymal cell (MSC) that is Neurokinin-1 receptor-positive (NK1R+). 
  • The trial is expected to start in Q3 of 2022.
  • Also See: Safety Board Recommends BioCardia's Heart Failure Cell Therapy To Continue Unchanged.
  • The first part of the clinical trial will evaluate increasing doses of the NK1R+ MSCs. The optimal dose will be taken to Phase II in a randomized study in adult patients recovering from ARDS due to COVID-19.
  • "After intravenous (IV) delivery, the cells migrate to the lungs for local therapeutic benefit. We expect the anti-inflammatory nature of these mesenchymal stem cells to positively impact ARDS because of the interaction of the Neurokinin-1 receptors with Substance P. This neuropeptide has long been known to be a primary mediator of inflammation in the lungs," said Ian McNiece, Ph.D., BioCardia's Chief Scientific Officer. 
  • Price Action: BCDA shares are up 22.3% at $2.63 during the premarket session on the last check Tuesday.
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