INmune Bio announced that the US Food and Drug Administration (FDA) has accepted the company’s investigational new drug (IND) application to initiate a Phase 2 clinical trial evaluating Quellor, a selective soluble tumour necrosis factor (sTNF) inhibitor, for the treatment of immune-mediated complications in COVID-19 patients.

“There is compelling evidence that TNF plays an outsized role in the pathology caused by the cytokine storm,” stated RJ Tesi, MD, CEO of INmune Bio. “We can now move to the clinic to determine if neutralizing soluble TNF, the master cytokine of the cytokine storm will blunt the effects of this dysregulated innate immune response to the SARS-CoV-2 virus without immunosuppressing the patient.”

The blinded randomised Phase 2 clinical trial (NCT04370236) will enrol 366 COVID-19 patients in two equal-sized cohorts: standard of care (SOC), which may include remdesivir or SOC plus Quellor given as a 1mg/kg subcutaneous injection on admission to the hospital. A second dose of Quellor may be given a week later if the patient remains hospitalised. The primary study endpoint is the need for mechanical ventilation during the 28 days following admission to the hospital, including CPAP, BiPAP or intubation. Secondary endpoints include transfer to the ICU, new onset neurologic, cardiovascular or thromboembolic disease, development of renal failure or death. The first 100 patients randomised into the study will provide proof-of-concept and inform a “go/no go” decision by the Data Safety Monitoring Board (DSMB). If the DSMB recommends that the trial continue, the remaining 266 patients will be enrolled.