INmune Bio, a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, 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 tumor 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, chief executive officer 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 randomized phase 2 clinical trial will enroll 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 hospitalized. 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 randomized 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.
Quellor is a next-generation inhibitor of tumor necrosis factor (TNF) that is different from currently existing non-selective TNF inhibitors. Quellor neutralizes soluble TNF (sTNF) using a novel dominant-negative biology that importantly does not affect trans-membrane TNF (tmTNF) or TNF receptors. Currently approved TNF inhibitors block both sTNF and tmTNF. Quellor could have beneficial effects in patients with immune mediated complications from COVID-19 by decreasing inflammation and inflammatory immune complications such as endothelial cell activation, a potentially important cause of COVID-19-related coagulopathy which is increasingly blamed for end-organ dysfunction in lungs, kidneys, heart and brain. By targeting only sTNF, Quellor does not cause immunosuppression that is typical of most anti-cytokine therapies including currently approved anti-TNF and anti-IL-6 therapies. This may be an advantage when treating patients with a life-threatening viral infection.