24 December 2020 - - US-based clinical-stage company EOM Pharmaceuticals, Inc has filed a pre-Investigational New Drug Application (pre-IND) meeting request and complete pre-IND briefing documents with the US Food and Drug Administration to discuss the company's plans to evaluate the safety and efficacy of its dual-acting, broad-spectrum immunomodulator drug candidate EOM613 in a Phase 2 clinical trial treating complications of hospitalized COVID-19 patients, including Acute Respiratory Distress Syndrome, the company said.

The pre-IND meeting request is supported by previously completed Phase 2 clinical trials with EOM613 in cachexic AIDS patients and advanced cancer patients with cachexia, a cytokine- and chemokine-related body wasting syndrome.

In those studies, EOM613 treatment was shown to be both safe and capable of mitigating the cytokine- and chemokine-driven symptoms of cachexia, stabilizing or increasing patient weight, and also improving quality-of-life measures such as the Karnofsky Performance Status and Simmonds Functional assessment scores.

About COVID-19-Associated Acute Respiratory Distress Syndrome
ARDS is a dangerous, potentially fatal respiratory condition in which the lungs acquire a widespread injury that reduces their ability to provide the body with enough oxygen.

The condition causes fluid buildup in the lungs, which in turn decreases blood oxygen to critically low levels.

ARDS is a medical emergency,6 and a major complication in severe cases of COVID-19, affecting 42% of patients presenting with COVID-19 pneumonia and 61–81% of those requiring intensive care.

ARDS also triggers an adverse immune response, causing a release of cytokines, a type of small protein that can cause inflammation in the lungs and other organs.

This inflammation, in combination with low levels of blood oxygen, can lead to such life-threatening problems as organ failure and sometimes multiple organ failure.

Certain risk factors increase the likelihood of the development of ARDS in people with COVID-19, including advanced age, diabetes, a history of cardiac disease and high blood pressure.

EOM613 is an investigational, first-in-class, dual-acting, broad-spectrum immunomodulator designed to provide both an anti-inflammatory effect at the site of cytokine and chemokine overactivity, and a pro-inflammatory effect, when needed.

EOM613 is designed to counteract the most severe inflammatory effects of viruses, such as cytokine storm or hyperimmune response following infection with the novel coronavirus that causes COVID-19, autoimmune attacks that cause joint damage and pain associated with rheumatoid arthritis, and cytokine- and chemokine-related body-wasting syndromes such as cachexia.

By re-establishing balance, EOM613 may rescue, repair, and restore an immune system that has been confronted by an invading antigen, pathogen, or virus.

This dual-acting, broad-spectrum approach may overcome a key limitation of conventional immunomodulators. It is administered as a subcutaneous injection, unlike conventional immunomodulators which often require intravenous infusion.