EOM Pharmaceuticals Receives FDA Clearance for Phase 2a Cancer Cachexia Trial of EOM613
核心洞察
EOM Pharmaceutical Holdings (搜索) announced FDA clearance of its IND application to conduct a three-month Phase 2a clinical study of EOM613 in cachectic cancer patients, addressing an unmet medical need with no approved therapies.
The open-label trial will enroll approximately 20 Stage 4 cancer patients to evaluate EOM613's effects on weight, lean body mass, appetite, and quality of life through daily subcutaneous administration.
EOM613 is a peptide nucleic acid-based immune regulating agent that targets pro-inflammatory and anti-inflammatory cytokines, previously showing beneficial effects in AIDS cachexia and COVID-19 patients.
EOM Pharmaceutical Holdings (搜索) announced that the FDA has cleared its Investigational New Drug (IND) application to conduct a three-month Phase 2a clinical study of EOM613 in cachectic cancer patients. The biotechnology company, focused on developing treatments for chronic inflammatory conditions and retinal diseases, received approval from the FDA's Office of Cardiology, Hematology, Endocrinology and Nephrology Diseases (OCHEND) to proceed with the open-label trial in Stage 4 cancer patients.
"EOM has designed a Phase 2a clinical trial for the treatment of cancer cachexia patients who currently have no approved therapies," stated Shalom Z. Hirschman, MD, Chief Medical Officer of EOM. "In previous clinical trials in cachectic AIDS patients and COVID-19 patients, EOM613 treatment was well-tolerated, even in extremely sick patients."
Addressing an Unmet Medical Need
Cancer cachexia represents a highly debilitating wasting syndrome exhibited by a large percentage of patients with advanced malignancies, characterized by weight loss, muscular weakness, anorexia, anemia, and hypoproteinemia. Cachectic patients often become debilitated and unable to tolerate rounds of chemotherapy. The condition is largely an inflammatory process driven by pro-inflammatory cytokines, including Interleukin-6, TNF-alpha (搜索), Interleukin-1-beta and Interferon-gamma, which induce protein degradation leading to muscle mass loss and hypermetabolism. Currently, no FDA-approved therapy exists for cancer cachexia.
Trial Design and Objectives
The open-label clinical trial will explore the effects of daily subcutaneous administration of EOM613 over three months on multiple parameters including weight, lean body mass, appetite, performance status and standardized measures of patient quality of life. The study will also assess safety and tolerability of EOM613 and examine how many patients become eligible for additional chemotherapy rounds due to functional improvements in strength and performance status.
Approximately 20 patients aged 18-80 are expected to enroll in the study. Patients at baseline must have a Karnofsky Performance Score of 40-80% and a life expectancy of at least four months. The trial will be conducted under Principal Investigator Azriel Hirschfeld, MD, at Hirschfeld Oncology (搜索) in Brooklyn, NY, who specializes in treating gastrointestinal cancer patients with advanced disease. Trial initiation is anticipated for early third quarter 2026.
EOM613 Mechanism and Previous Results
EOM613 is a peptide nucleic acid-based broad spectrum immune regulating agent that acts on both key pro-inflammatory and anti-inflammatory cytokines. The agent has demonstrated the ability to regulate cytokine expression in immune cells in cell culture and has shown beneficial effects in open-label clinical trials for rheumatoid arthritis and AIDS cachexia. In a Health Canada-approved clinical trial, EOM613 demonstrated beneficial effects in stabilizing weight and improving functional status of Stage 4 cancer patients with cancer cachexia.
"A broad-spectrum immune regulating agent that regulates pro-and anti-inflammatory cytokines in patients without the risk of severe side effects could prove to be beneficial in the treatment of cancer cachexia, which is largely a cytokine-driven process," Hirschman noted.
Expansion into Inflammatory Bowel Disease
EOM is also planning an additional exploratory, open-label EOM613 clinical trial in Crohn's disease, scheduled to begin in fourth quarter 2026. The trial will be conducted at clinical sites in New Brunswick and Lakewood, NJ, under Principal Investigator Arkady Broder, MD, Director of Gastroenterology at the St. Peter's Healthcare System (搜索).
The Crohn's disease trial plans to enroll 15 to 20 subjects with moderate to severe disease who have failed or could not tolerate at least one conventional therapy. The study will test for signs of both clinical remission and endoscopic remission with EOM613 monotherapy treatment while measuring biomarkers including C-reactive protein, calprotectin and pro-inflammatory serum cytokines.
The pathophysiology of inflammatory bowel disease, including Crohn's disease and ulcerative colitis, is largely driven by inflammatory cytokines in the gastrointestinal tract, particularly TNF-alpha (搜索), interleukin 12 (IL-12), interleukin-23 (IL-23) and soluble Interleukin 2 receptor (sIL-2R), making it another potential target for EOM613's broad-spectrum immune regulation approach.