Humanigen Inc. (NASDAQ: HGEN) has announced that the FDA has declined its Emergency Use Authorization application for lenzilumab in treating newly hospitalized coronavirus patients.
FDA declines Humanigen’s EUA for lenzilumab in COVID-19 treatment
The FDA noted in a letter to the company that it was unable to determine whether the known and possible advantages of lenzilumab exceed the known and possible dangers of its usage as a COVID-19 therapy.
CEO Cameron Durrant said, “We remain committed to bringing lenzilumab to patients hospitalized with COVID-19. We believe the ongoing ACTIV-5/BET-B trial, which has been advanced to enroll up to 500 patients, may provide additional safety and efficacy data sufficient to support our efforts to obtain an EUA to treat hospitalized COVID-19 patients.”
Lenzilumab has shown the potential of minimizing “cytokine storm”
The clinical-stage biopharma focuses on developing therapies to prevent and treat immune hyper-response described as “cytokine storm. Lenzilumab is an exceptional antibody the company is developing that binds to granulocyte-macrophage colony-stimulating factor (GM-CSF) and neutralizes it. As per preclinical models, GM-CSF is an upstream regulator of several inflammatory chemokines and cytokines involved in the cytokine storm. For example, investigations early in the COVID-19 pandemic revealed that high levels of GM-CSF secreting T cells were linked to disease severity and ICU hospitalization.
Early intervention with lenzilumab, according to Humanigen’s Phase 3 LIVE-AIR research, may avert the effects of a full-blown cytokine storm in hospitalized COVID-19 patients. The company has submitted the drug to the UK’s Medicines and Health Regulatory Agency for a rolling evaluation in the hopes of gaining Marketing Authorization. In addition, Humanigen is developing lenzilumab as a treatment for cytokine storm caused by COVID-19 and CD19-targeted CAR-T cell therapies and looking into its efficacy in other inflammatory conditions like acute Graft versus Host Disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation, rheumatoid arthritis, and eosinophilic asthma.