Type: Engineered (Humaneered®) anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to prevent and treat cytokine storm.
Status: Humanigen said July 27 that it signed a clinical trial agreement with the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID) to evaluate lenzilumab in the NIAID-sponsored Big Effect Trial (BET) in hospitalized patients with COVID-19.
BET is intended to build on initial data from NIAID’s Adaptive COVID-19 Treatment Trial (ACTT), which showed that Gilead’s remdesivir may improve time to recovery in hospitalized patients with COVID-19. BET is designed to assess the combination of lenzilumab and remdesivir on treatment outcomes versus placebo and remdesivir in hospitalized COVID-19 patients. The trial is expected to enroll 100 patients in each arm of the study with an interim analysis for efficacy after 50 patients have been enrolled in each arm, Humanigen said.
“With data from the BET and our ongoing Phase III study, we will have data from approximately 500 hospitalized COVID-19 patients,” stated Humanigen CEO Cameron Durrant, MD, MBA.
In June, Mayo Clinic researchers published a preprint study at medRxiv.org showing positive data associated with a Phase III potential registration study (NCT04351152) that the company said was the first clinical use of lenzilumab in 12 COVID-19 patients hospitalized in Mayo’s system with severe or critical pneumonia due to the virus. Lenzilumab led to rapid clinical improvement with a median time to recovery of five days, median time to discharge of five days, and 100% survival to the data cutoff date. Patients also showed rapid improvement in oxygenation, temperature, inflammatory cytokines, and key hematological parameters consistent with improved clinical outcomes, Humanigen added.
At the data cut-off point, according to Humanigen CEO Cameron Durrant, MD, MBA, 11 of the 12 patients were discharged from the hospital. All 12 had at least one risk factor associated with poor outcomes, such as age, smoking history, cardiovascular disease, diabetes, chronic kidney disease, chronic lung disease, high BMI, and elevated inflammatory markers, with several patients having multiple such risk factors. The patients, who were hospitalized in the Mayo Clinic system, all required oxygen supplementation and had elevation in at least one inflammatory biomarker prior to receiving lenzilumab.
All patients had at least one co-morbidity associated with poor outcomes in COVID-19, with several patients having multiple co-morbidities: 58% had diabetes mellitus, 58% had hypertension, 58% had underlying lung diseases, 50% were obese (defined as a BMI greater than 30), 17% had chronic kidney disease and 17% had coronary artery disease. The median age was 65 years.
On June 16, Humanigen released additional analysis of the data comparing patients with similar baseline characteristics treated with lenzilumab to patients treated with Gilead Sciences’ remdesivir. Patients treated with lenzilumab for a single day showed rapid clinical improvement with a median time to improvement of five days and a median time to recovery of five days—compared with a median time of 10 days for both measures in patients treated with remdesivir over 5 days, and a median of 11 days for both measures in patients treated 11 days with remdesivir.
Neither data set included a placebo arm, and the lenzilumab cohort was small, Humanigen acknowledged.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: