Humanigen Inc. (NASDAQ:HGEN) has announced the publication of a patient case report on lenzilumab™ use in critical COVID-19 at OSF Preprints. The company has also offered updates on lenzilumab in a COVID-19 program which includes written guidance from the FDA following Type B meeting for feedback of Emergency Use Authorization (EUA).
Humanigen offers updates on Type B meeting for lenzilumab
According to the FDA, Humanigen’s planned submission is sufficient to support EUA requests subject to the Phase 3 trial results. Equally, the company has announced more updates in Phase 3 lenzilumab registration study, which is enrolling subjects in Brazil and The US and has been approved for expansion to Mexico. The double-blind, placebo-controlled, randomized phase 3 study has 29 approved study sites with 24 of those actively enrolling hospitalized patients with COVID-19 who are at risk of disease progression or who need supplemental oxygen.
Humanigen CEO Cameron Durrant said that the FDA has helped the company and has offered clear guidance on the EUA submission plan. He added that they are encouraged by the Type B meeting with the FDA, and they are upbeat in their program and preparedness plans in advancing the EUA.
Chief Scientific Officer Dale Chappell said that lenzilumab is among the few third phase treatment alternatives currently in development for the treatment of COVID-19. Dale added that lenzilumab has the potential of being a first-line treatment that can improve recovery time and also mitigate potentially fatal and serious outcomes in hospitalized COVID-19 patients.
Lenzilumab shows positive response in COVID-19 patient
The case report that the company published on OSF Preprints was titled “Covid-19 associated chronic ARDS Successfully treated with lenzilumab.” In the case, the company describes a 77-year-old Caucasian adult male patient that tested positive for SARS-CoV-2 and was in ICU for COVID-19. Following the use of lenzilumab on the patients, there was a decrease in the patient’s oxygen flow from high to low flow nasal cannula, and the patient managed to leave the hospital room. The patient was discharged after 16 days following treatment with lenzilumab.