Announcement • Jan 07
EOM Pharmaceutical Holdings, Inc. Reports Promising Preclinical Results and Provides an Update on EOM613 and EOM147 EOM Pharmaceutical Holdings, Inc. provided an update on its preclinical programs in 2025 and its planned clinical activities in 2026 for its two lead product candidates EOM613 and EOM147. In 2025, the company completed IND-enabling toxicological and dosing preclinical animal studies for EOM613 with favorable results. In addition, no adverse effects were seen in tissue upon histopathological testing. Based on these data, combined with previously reported promising results of Phase I/IIa 2023 human clinical trial in hospitalized COVID-19 patients with cytokine-driven respiratory inflammation in Brazil, the company planning an initial Phase II exploratory clinical trial in patients with Crohn's disease. This trial is designed to include 15-20 patients and 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. The trial will enroll subjects with moderate to severe Crohn's disease who have failed or could not tolerate at least one conventional therapy. EOM anticipates initiating the trial in the first quarter 2026 to test for signs of clinical remission and endoscopic remission with EOM613 treatment and to measure biomarkers such as C-reactive protein, calprotectin and pro-inflammatory serum cytokines. In addition, based on these preclinical results, EOM plans to reactivate an Investigational New Drug (IND) application for the treatment of cachectic cancer patients at the FDA's Office of Oncologic Diseases (OOD) with a view to conducting an open-label Phase II trial with Stage 4 cancer patients. The trial's Principal Investigator is Azriel Hirschfeld, MD, at Hirschfeld Oncology in Brooklyn, NY, an expert in the treatment of gastrointestinal cancer patients with advanced disease who typically progress to a cachectic condition. In previous clinical trials in AIDS, cancer cachexia and COVID-19 patients, EOM613 treatment was well-tolerated, even in very sick patients. A broad-spectrum immune regulating agent that regulates pro-and anti-inflammatory cytokines in patients without the risk of severe side effects associated with the use of antibody or corticosteroid drugs could be beneficial in the treatment of Crohn's disease and ulcerative colitis. Announcement • Sep 08
EOM Pharmaceutical Holdings Announces Topline Results of Its Covid-19 Clinical Trial of Eom613 in Brazil EOM Pharmaceutical Holdings, Inc. announced the results of its completed clinical trial in hospitalized COVID-19 patients with severe symptoms treated with its investigational immune-regulating drug product EOM613. The trial was conducted in Brazil. This exploratory Phase 1/2a clinical trial (NCT05212532), designated RESCUE, was a proof-of-concept, open-label study evaluating the safety, tolerability, and preliminary efficacy measures, such as the effects on serum cytokines, when EOM613 was added to the standard-of-care therapy. The trial included two cohorts of patients hospitalized for COVID-19: one cohort was in the intensive care unit (ICU) and the other cohort was not (non-ICU). The study was conducted at four different medical centers in the Brazilian states of Sao Paolo and Goaia. The trial was originally designed to enroll a total of 40 patients – 20 in each cohort. The trial was redesigned, however, due to challenges in patient enrollment during the COVID-19 pandemic as a result of Brazil's successful vaccination program which led to a reduction in eligible hospitalized patients. The redesigned trial enrolled a total of 23 patients eligible for evaluation. The study's Principal Investigator was Florentino Cardoso Filho, MD, at the Casa de Saude Hospital in Campinas, Sao Paolo, and former President of the Brazilian Medical Association. Announcement • Aug 03
EOM Pharmaceuticals Holdings, Inc. has withdrawn its IPO in the amount of $15 million. EOM Pharmaceuticals Holdings, Inc. has withdrawn its IPO in the amount of $15 million.
Security Name: Common Stock
Security Type: Common Stock