EOM Pharmaceutical Holdings, Inc. announced the results of its completed clinical trial in hospitalized COVID-19 patients with severe symptoms treated with its investigational immune-regulating drug product EOM613. The trial was conducted in Brazil. This exploratory Phase 1/2a clinical trial (NCT05212532), designated RESCUE, was a proof-of-concept, open-label study evaluating the safety, tolerability, and preliminary efficacy measures, such as the effects on serum cytokines, when EOM613 was added to the standard-of-care therapy.

The trial included two cohorts of patients hospitalized for COVID-19: one cohort was in the intensive care unit (ICU) and the other cohort was not (non-ICU). The study was conducted at four different medical centers in the Brazilian states of Sao Paolo and Goaia. The trial was originally designed to enroll a total of 40 patients ?

20 in each cohort. The trial was redesigned, however, due to challenges in patient enrollment during the COVID-19 pandemic as a result of Brazil's successful vaccination program which led to a reduction in eligible hospitalized patients. The redesigned trial enrolled a total of 23 patients eligible for evaluation.

The study's Principal Investigator was Florentino Cardoso Filho, MD, at the Casa de Saude Hospital in Campinas, Sao Paolo, and former President of the Brazilian Medical Association.