Congratulations to INmune Bio! Tranquil is proud to be a part of this tremendous effort on enrolling the first patient to this important study.
LA JOLLA, Calif, Nov. 09, 2020 (GLOBE NEWSWIRE) — INmune Bio, Inc. (NASDAQ: INMB) (the, “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, announced today 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.
“Clinical evidence over the last several months has shown that while infection with COVID-19 virus makes people sick, it’s the uncontrollable immune response and subsequent cytokine storm that is responsible for their admission to a hospital,” stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. “By neutralizing TNF, the master inflammatory cytokine of the cytokine storm with Quellor, we believe Quellor™ can blunt the symptoms of this dysregulated immune response. This US based clinical trial expands both our geographic and therapeutic footprint with our DN-TNF platform.”
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.
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