reticulose (EOM613) / EOM Pharma - LARVOL DELTA

EOM Pharmaceutical Holdings Provides an Update on its Lead Drug Candidate EOM613 (BioSpace) - "EOM Pharmaceutical Holdings, Inc...provides an update on its clinical program for its lead drug candidate EOM613....This clinical finding is of particular interest since the pathophysiology of inflammatory bowel disease (IBD) is known to be largely driven by the release of inflammatory cytokines in the gastrointestinal tract, in particular TNF-alpha, interleukin 12 (IL-12), interleukin-23 (IL-23) and sIL-2R. In light of these clinical trial results, the company is currently preparing to initiate an EOM613 clinical program in Crohn's disease."

Clinical • Crohn's disease • Immunology • Inflammatory Bowel Disease

EOM Pharmaceutical Holdings Announces Topline Results of its COVID-19 Clinical Trial of EOM613 in Brazil (PRNewswire) - P1 | N=40 | NCT05212532 | Sponsor: EOM Pharmaceuticals | "EOM Pharmaceutical Holdings, Inc...today 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....EOM613 treatment produced a reduction in certain pro-inflammatory serum cytokine levels in line with its postulated mechanism of action of immune modulation....Post-baseline clinically significant beneficial changes were seen with EOM613 treatment for two of the blood serum cytokines involved in the cytokine storm in hospitalized COVID-19 patients, namely, soluble interleukin-2 receptor (sIL-2R) and interleukin-10 (IL-10). In the seriously affected ICU cohort, changes were also observed in other cytokines, such as TNF-α, IL-1β, IL-6 and IL-13, in line with EOM613's mechanism of action..."

P1 data • Immunology • Infectious Disease • Novel Coronavirus Disease

A Proof-of-Concept Study Evaluating EOM613 in COVID-19 Infected Patients With Severe Symptoms (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: EOM Pharmaceuticals

New P1 trial • Acute Respiratory Distress Syndrome • Immune Modulation • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • IL10 • IL2 • IL6 • PCR

EOM Pharmaceuticals Announces Its Pre-IND Meeting Request With U.S. FDA to Evaluate Plans for a Phase 2 Clinical Trial of Its Investigational Dual-Acting, Broad-Spectrum Immunomodulator in COVID-19 Patients (Businesswire) - "EOM Pharmaceuticals, Inc....announced it has filed a pre-Investigational New Drug Application (pre-IND) meeting request and complete pre-IND briefing documents with the U.S. Food and Drug Administration (FDA) to discuss the company’s plans to evaluate the safety and efficacy of...EOM613 in a Phase 2 clinical trial treating complications of hospitalized COVID-19 patients, including Acute Respiratory Distress Syndrome (ARDS)....'We look forward to finalizing our Phase 2 clinical study design and protocol for EOM613 with the advice and guidance of the FDA and to initiating our trial at a leading university medical center in the United States...'"

FDA event • Infectious Disease • Novel Coronavirus Disease

A Phase II Open Label, Multi-Center Study With AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies (clinicaltrials.gov) - P2; N=30; Terminated; Sponsor: McGill University; Recruiting ➔ Terminated; Study transferred out of McGill because PI relocted to another insitution.

Clinical • Trial termination