BioCardia Inc (NASDAQ: BCDA) Inc has received approval from the FDA for its Investigational New Drug Application (IND). The IND is for its BCDA-04 therapy, which treats Acute Respiratory Distress Syndrome (ARDS). The IND will allow the company to begin its Phase 1/2 clinical study on patients who previously had COVID-19 induced ARDS.
Phase 1 will include a dose testing exercise to examine the effect and safety of increasing the dose. Researchers will then use these results in a Phase 2 trial, which will consist of a study to evaluate the efficacy of the drug on patients with ARDS after a previous diagnosis of COVID-19.
How the therapy works
According to the Chief Scientific Officer at the company, Ian McNiece, the BioCardia is conducting this study because of positive results from past work and investigations. McNiece explained that researchers give the drug intravenously.
After administering BCDA-04, the cells move to the patients’ lungs to provide therapeutic effects. The company believes that the mesenchymal stem cells that make part of the treatment will benefit the patient since they react to Substance P. Substance P, a neuropeptide, plays a role in lung inflammation.
The company will administer the drug to patients undergoing a recovery period after ARDS. BCDA-04 is to prevent them from developing respiratory problems in the future while speeding up their recovery.
Mesenchymal cell therapy has many applications
The CEO of BIocardia, Peter Altman, adds that the company has achieved many of its milestones. The IND approval is one of them. Others include evaluating its cell therapies for myocardial ischemia and other diseases.
Moreover, the creation of mesenchymal therapy shows that the applications of these treatments could go beyond cardiac implications. The company has sold its mesenchymal stem cells therapy for several indications since it has Neurokinin-1, a substance that binds to receptors of Substance P.
ARDS caused a fluid buildup in the lung alveoli. As a result, the alveoli can’t carry oxygen in their intended capacity, and less of the gas gets to the bloodstream. For this reason, the body doesn’t have enough oxygen. Some of the disease symptoms are fast breathing and dyspnea.