Humanigen Inc. (NASDAQ:HGEN) has announced encouraging topline results from its third phase clinical study evaluating the safety and efficacy of lenzilumab in treating hospitalized COVID-19 patients.
Lenzilumab improved patient outcomes in COVID-19 patients
The study results demonstrated that patients treated with lenzilumab and other treatments like remdesivir or/and steroids had a 54% more chance of survival without needing IMV relative to patients under placebo and other treatments. Most importantly, the results were statistically significant.
Cameron Durrant, the Humanigen CEO, said that the results from the third phase lenzilumab treatment study showed better outcomes in hospitalized patients with hypoxic COVID-19 that had not progressed to require IMV. Equally, the study incorporated a diverse population with different comorbidities, with the most common being body mass index above 30, representing the high-risk population in the real-world. Durrant said that the company’s next step is submitting Emergency Use Authorization application to the FDA immediately. He said that they are also sharing the results with Government Agencies in the US as well as other authorities globally.
Mayo Clinic’s Molecular Medicine Department Head Andrew Badley said that they are pleased to have participated in the lenzilumab investigation from the initial stages of the COVID-19 development program, and they are delighted with the results. Badley said that if the FDA authorizes lenzilumab for emergency use and based on the company’s clinical study experience, it will be considered as part of the treatment armamentarium for newly hospitalized COVID-19 patients.
The study achieved the primary endpoint
The study findings show that lenzilumab considerably enhanced patient outcomes and achieved the primary ventilator-free survival endpoint measured four weeks after treatment. Most importantly, ventilator-free survival is a reliable and validated measure used in trials to evaluate respiratory distress. Although the trial was not designed to show mortality difference, a favorable mortality trend was observed in the lenzilumab treatment arm relative to the placebo arm.
Principal study investigator Zelalem Temesgen said that the findings strongly indicated improved outcomes in hospitalized COVID-19 pneumonia patients. The dosing regimen used in the study was designed for hospitalized COVID-19 pneumonia patients.