Humanigen announces positive interim results for lenzilumab in COVID-19 phase 3 trial

Humanigen, a U.S.-based biopharmaceutical company, has revealed promising interim data from its phase 3 clinical trial of lenzilumab, a monoclonal antibody designed to treat COVID-19. According to the data, lenzilumab has demonstrated a clinically meaningful impact on the recovery of hospitalized patients suffering from severe COVID-19 pneumonia. This breakthrough comes as the company seeks to provide an innovative solution to combat the virus, particularly in severe cases where the immune system’s overreaction, known as cytokine release syndrome (CRS), can significantly worsen patient outcomes.

Positive interim data and implications for treatment

The phase 3 trial, which is randomized, placebo-controlled, and double-blinded, aims to assess the effectiveness of lenzilumab in combination with the standard of care (SOC) for patients with severe or critical COVID-19. According to Humanigen, the interim analysis indicates a significant improvement in recovery rates for patients treated with lenzilumab compared to those receiving SOC alone.

Based on this interim data, Humanigen reported that patients receiving lenzilumab experienced 37% more recoveries than those on the current SOC, a promising outcome that suggests lenzilumab could be a potential frontline treatment for COVID-19 patients. This finding comes as a ray of hope for the healthcare community, which continues to search for effective treatments to manage the deadly virus, especially given the challenges associated with remdesivir and steroid use in certain patient populations.

Cameron Durrant, CEO of Humanigen, expressed confidence in these findings, stating, “These interim data demonstrate the potential of lenzilumab as a frontline treatment option for patients hospitalized with COVID-19.” He added that the company is encouraged by the clinically meaningful impact that lenzilumab could have, especially considering its potential to improve outcomes beyond existing treatments such as remdesivir and steroids.

Focus of the phase 3 trial and next steps

The primary goal of the trial is to evaluate the effectiveness of lenzilumab in reducing the immune-mediated cytokine release syndrome (CRS) in COVID-19 patients. CRS is a serious complication of COVID-19 that can lead to severe inflammation and tissue damage, making it one of the key contributors to the deterioration of critically ill patients.

Humanigen has designed the trial with an adaptive model, meaning it allows for the modification of the study based on interim data. The Data Safety Monitoring Board (DSMB), after reviewing the unblinded data, recommended expanding the target number of recoveries in the trial from 257 to 402. This adjustment aims to maintain the statistical power of the study at 90%, ensuring a higher likelihood of obtaining conclusive results.

As part of the plan to meet this new target, Humanigen intends to enroll an additional 150 patients, bringing the total enrollment to approximately 515 participants. The company believes this increase will not only enhance the trial’s robustness but also boost the probability of success in meeting its primary endpoint.

Dale Chappell, Chief Scientific Officer of Humanigen, explained that the DSMB’s recommendation to expand the trial was a significant step toward ensuring the study’s success. “We believe the Phase 3 trial is significantly de-risked,” Chappell said, adding that this strategic increase in the number of patients would improve the probability of success and support future applications for Emergency Use Authorization (EUA) and Biologics License Application (BLA).

The path ahead for lenzilumab

Looking ahead, Humanigen plans to file for Emergency Use Authorization (EUA) for lenzilumab in the first quarter of 2021, either after the interim data is finalized at the 75% event threshold or upon completion of the entire study. The company is also actively working to expand its clinical trial network across the U.S. to expedite patient enrollment and increase access to the treatment, all while prioritizing inclusion and diversity in the study population.

The upcoming interim analysis, expected to take place once 75% of the targeted events (approximately 302 recoveries) have been reached, could provide further insight into lenzilumab’s potential effectiveness in treating COVID-19. With these ongoing developments, lenzilumab remains a promising candidate for addressing one of the most critical challenges in the global fight against the pandemic.