Baylx, a clinical-stage stem cell biopharmaceutical company focused on developing living stem cell products to address unmet medical needs, announced that the US Food and Drug Administration (FDA) has cleared Baylx's Investigational New Drug (IND) application for BX-U001, a fresh, non-frozen human umbilical cord tissue mesenchymal stem cells (hUC-MSC) product in patients with COVID-19.
Mesenchymal stem cells hold great promise to treat COVID-19 patients due to their potential in inhibiting the overactivated immune system and promoting the recovery of pulmonary and other organs’ failure in severe COVID-19 cases.
“We are excited to have received clearance for this IND, which will enable us to evaluate the safety and efficacy of hUC-MSCs in COVID-19 patients in the United States,” said Dr. Wenbin Liao, Chief Executive Officer of Baylx, Inc. “We look forward to working with investigators to initiate the trial in California, the state with most confirmed COVID-19 cases in the United States currently.”
This Phase 1/2a clinical trial of Baylx will recruit approximately 30 COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS), an acute hypoxemic respiratory failure with high mortality rate. Currently there is no drug available to treat ARDS or COVID-19.
Cytokine storm, as defined by increased levels of a set of proinflammatory cytokines, plays an important role in the pathogenesis of ARDS and the clinical progress of COVID-19 patients. Previous data from many groups, including Baylx, have demonstrated that hUC-MSC can decrease the level of multiple proinflammatory cytokines by modulating the immune cells or secreting anti-inflammatory factors in both preclinical or clinical studies of inflammatory diseases.
The immunomodulatory activities of hUC-MSC support their potential clinical use to combat the hyperinflammation status and improve the prognosis in ARDS of COVID-19 patients.
“We are hopeful that BX-U001 can be an effective treatment for COVID-19 patients, especially for those affected by ARDS,” said Dr. Liao.
This is Baylx’s second IND clearance from FDA in three months. In early June this year, Baylx also received the clearance of an IND from US FDA for the same product, BX-U001, in the treatment of rheumatoid arthritis (RA).
Source: Company Press Release