Humanigen to Seek EUA for its COVID-19 Antibody Treatment
Humanigen said it will seek an FDA Emergency Use Authorization for its monoclonal antibody lenzilumab “as soon as possible” based on positive results from a phase 3 clinical trial that showed the drug significantly reduced the risk of death for hospitalized COVID-19 patients.
Patients in the late-stage study who received lenzilumab, along with other treatments, such as steroids and/or Gilead Sciences’ remdesivir, saw a 54 percent increase in the likelihood of survival after 28 days when compared with patients given a placebo and other treatments, the company said. The trial enrolled an estimated 520 adults across 29 clinics in the U.S. and Brazil.
Lenzilumab is meant to alleviate the symptoms of cytokine release syndrome, an immune system malfunction seen in many COVID-19 patients that can cause low oxygen levels in the lungs.
Humanigen CEO Cameron Durrant said the trial included “a diverse population with various comorbidities, most commonly a body mass index above 30, which is representative of a real-world, high-risk population.”
The company did not release the full trial data, but said it will submit the results to a peer-reviewed journal. ― Jason Scott