EOM Pharmaceuticals has dosed the first patient in R1: RESCUE, a proof-of-concept Phase I/IIa open-label multi-centre clinical study in Brazil to evaluate safety, tolerability, and preliminary efficacy of EOM613 in hospitalised Covid-19 infected patients with severe symptoms.
Irach B. Taraporewala, Chief Executive Officer and Director of EOM, said: “This is the first step in clinically evaluating what we believe is EOM613’s unique mechanism of action to address cytokine storms in Covid-19 patients. The study reinforces our commitment to pursue innovative approaches to meet urgent and unmet global medical needs.”
The R1: RESCUE study is intended to inform the Brazil regulatory pathway, which could include an Emergency Use Authorisation (EUA) and full ANVISA regulatory approval. The trial will be recruiting hospitalised Covid-19 patients at hospital sites in Brazil. It will last 28 days and is expected to enroll approximately 40 patients to assess the safety, tolerability, and preliminary efficacy of EOM613 in non-ICU hospitalised patients and ICU hospitalised patients.
The primary endpoint is safety and tolerability of EOM613 in hospitalised Covid-19 patients. The secondary endpoints are the effect of EOM613 on selected anti- and pro-inflammatory cytokines, and correlation of changes in cytokine levels with clinical outcomes, such as time to discharge from the hospital or ICU. EOM expects to announce data from this trial in the fourth quarter of 2021.