(RTTNews) - EOM Pharmaceuticals Holdings Inc. (IMUC), a clinical-stage biotechnology company, on Wednesday reported FDA clearance of the investigational new drug (IND) application for EOM613 in treating cancer cachexia, allowing for the initiation of the Phase 2a clinical trial.
Cancer cachexia is a debilitating wasting syndrome experienced by cancer patients on chemotherapy, marked by severe weight and muscle loss, anorexia, anemia, and hypoproteinemia. It is caused by an inflammatory process producing cytokines that degrade proteins, leading to hypermetabolim and muscle wasting. There are no FDA-approved treatments for cancer cachexia.
EOM's lead drug candidate, EOM613, is a peptide nucleic acid-based broad spectrum immune regulating agent that targets anti-inflammatory and pro-inflammatory cytokines. It has previously shown good results in treating rheumatoid arthritis and AIDS cachexia.
The open-label Phase 2a trial was approved by the FDA's Office of Cardiology, Hematology, Endocrinology and Nephrology Diseases (OCHEND). The study is expected to dose up to 20 patients with Stage 4 malignancies over 3 months. Patients at the baseline will have Karnofsky Performance Score of 40-80%, and a minimum life expectancy of four months.
EOM613 will be administered daily through a sub-cutaneous route, and its effect assessed by measuring weight, lean body mass, appetite, circulating cytokine levels and quality of life. Safety and tolerability of the drug will also be determined. The trial is anticipated to begin in the third quarter of 2026.
EOM613 is also being advanced in a planned open-label trial with 15-20 patients for the treatment of Crohn's disease.
IMUC is currently trading on the OTC market at $0.11, down 4.35%.
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