Quellor (DN-TNF) / INmune Bio, Xencor - LARVOL DELTA

INB03 for the Treatment of Pulmonary Complications From COVID-19 (clinicaltrials.gov) - P2/3 | N=79 | Terminated | Sponsor: Inmune Bio, Inc. | N=366 ➔ 79 | Trial completion date: Feb 2021 ➔ Nov 2021 | Recruiting ➔ Terminated | Trial primary completion date: Feb 2021 ➔ Oct 2021; Futility

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

INmune Bio, Inc. Announces First Patient Dosed in Phase 2 Trial of Quellor for Pulmonary Complications in COVID-19 Patients (GlobeNewswire) - "INmune Bio, Inc....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....The dosing of the first patient took place at UofL Health – Jewish Hospital, Louisville, KY....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)."

Cytokine storm • Trial status • Infectious Disease • Novel Coronavirus Disease

INB03 for the Treatment of Pulmonary Complications From COVID-19 (clinicaltrials.gov) - P2/3; N=366; Recruiting; Sponsor: Inmune Bio, Inc.; Not yet recruiting ➔ Recruiting; Initiation date: Jul 2020 ➔ Oct 2020

Clinical • Enrollment open • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

INmune Bio, Inc. Announces FDA Acceptance of IND Application to Evaluate Quellor in a Blinded Randomized Phase 2 Trial for Immune Mediated Complications in COVID-19 Patients (GlobeNewswire) - "INmune Bio, Inc....announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application to initiate a Phase 2 clinical trial evaluating Quellor™...for the treatment of immune mediated complications in COVID-19 patients....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™....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."

Cytokine storm • IND • New P2 trial • Infectious Disease • Novel Coronavirus Disease

INmune Bio, Inc. Announces Second Quarter 2020 Results and Provides Business Update (GlobeNewswire) - "Upcoming Milestones: Report additional data on Phase 1b XPro1595 in Alzheimer’s Disease in 2H 2020; Enroll first patient in Phase II Quellor™ program, targeting COVID-19 patients with immune mediated complications from COVID-19."

Enrollment status • P1 data • Alzheimer's Disease • CNS Disorders • Infectious Disease • Novel Coronavirus Disease