INmune Bio, Inc. announced that the first patient has been dosed in its Phase 2 clinical trial evaluating Quellor for the treatment of pulmonary complications from COVID-19. Quellor is a selective soluble Tumor Necrosis Factor (sTNF) inhibitor designed to potentially prevent the progression of immune mediated pulmonary complications resulting from SARS-CoV-2 viral infection. The dosing of the first patient took place at UofL Health – Jewish Hospital, Louisville, KY. As the largest academic health system in Kentucky, UofL Health is committed to increasing regional access to leading edge treatments and therapies. The double-blind, randomized, placebo-controlled Phase 2 clinical trial (NCT04370236) will enroll 366 COVID-19 high risk patients in two equal sized cohorts: standard of care (SOC), which may include remdesivir, and 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. High risk patients include the elderly, patients with diabetes, cardiovascular disease, obesity, African American or Hispanic ethnicity. 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. UofL Health is a fully integrated regional academic health system with five hospitals, four medical centers, nearly 200 physician practice locations, more than 700 providers, the Frazier Rehab Institute and James Graham Brown Cancer Center. With more than 12,000 team members – physicians, surgeons, nurses, pharmacists and other highly skilled health care professionals, UofL Health is focused on one mission—one purpose—delivering patient-centered care to each and every patient—each and every day.