EOM Pharmaceuticals has dosed the first subjects in the proof-of-concept Phase I/IIa R¹: RESCUE clinical trial of its lead asset, EOM613, in hospitalised Covid-19 patients with severe symptoms in Brazil.
An experimental peptide-nucleic acid solution immunomodulator, EOM613 is said to exhibit anti-inflammatory and pro-inflammatory broad-spectrum cytokine effects.
The open-label, multi-centre Phase I/IIa R¹: RESCUE trial is assessing the safety, tolerability and preliminary efficacy of EOM613 in severe Covid-19 patients with ‘cytokine storm’ immune responses.
It will enrol nearly 40 subjects at various hospitals in Brazil, irrespective of their intensive care unit (ICU) admission status.
The safety and tolerability of the drug in hospitalised Covid-19 patients will be the trial’s primary goal.
The impact of EOM613 on certain anti-inflammatory and pro-inflammatory cytokines, as well as the link between cytokine level changes and clinical outcomes, including time to hospital or ICU discharge, will be the secondary goals.
EOM anticipates reporting results from the trial in the fourth quarter this year.
The trial is expected to inform the regulatory pathway in Brazil, including potential Emergency Use Authorization (EUA) and full regulatory approval from the Brazilian Health Regulatory Agency (ANVISA).
EOM Pharmaceuticals CEO and director Irach Taraporewala said: “We are pleased to announce the first patients have been dosed in our Phase I/IIa open-label trial.
“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.”
EOM613 showed a ‘dynamic dual action’ by suppressing or inducing monocytes and macrophages based on the activation state and environment of those vital immune cells in human cell culture studies.
The company noted that this dual action can potentially overcome a limitation of various approved immunomodulators that reduce the inflammatory state alone, without attaining immune system balance.