Humanigen is prepping its COVID-19 drug lenzilumab for an emergency use authorization with the FDA before the month’s end.
This is according to its financials out Thursday after-hours in which the biotech said it had “recently held a meeting with FDA” to discuss the filing of an EUA for lenzilumab, specifically for hospitalized, hypoxic COVID-19 patients, “at the end of May.” It is also seeking a biologics license application for its drug in the same setting, though it may need more trials for a full approval.
The EUA application comes after top-line data from its recent phase 3 that showed lenzilumab in hospitalized COVID-19 patients met its primary endpoint.
Lenzilumab targets GM-CSF, a cytokine associated with negative outcomes in COVID-19 patients. By neutralizing the cytokine, drug developers including Humanigen and GlaxoSmithKline have predicted that they may be able to counter life-threatening complications that arise when the immune system reacts particularly strongly to the virus.
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To test the hypothesis, investigators randomized 520 hospitalized COVID-19 patients to receive an infusion of lenzilumab or placebo on top of standard-of-care treatments such as dexamethasone or Gilead Sciences' Veklury.
After 28 days, the rate of ventilator-free survival was higher in the lenzilumab arm, causing the trial to hit its primary endpoint with a p-value of 0.0365. Humanigen changed the primary endpoint twice in the months after initiating the phase 3 trial in April 2020.
In the treatment group, the Kaplan-Meier estimate for invasive mechanical ventilation and/or death was 15.6% compared to 22.1% in the placebo group. Humanigen also reported a “favorable trend” in the mortality rate, which was 9.6% in the lenzilumab arm and 13.9% in the placebo group.
Humanigen said it has also been talking with U.K. drug regulator the Medicines and Healthcare products Regulatory Agency and is plotting a rolling submission “before the end of the second quarter of 2021,” with similar plans for Europe.
“We are encouraged by the achievements Humanigen has made since the beginning of 2021 and by our progress on the emergency use authorization application,” said Cameron Durrant, M.D., CEO at Humanigen.
The biotech’s shares jumped 13% premarket Friday.