Enlivex's Phase 2 Sepsis Trial Fully Enrolled

Sepsis, a severe medical condition, is an emergency that occurs when the body's response to an infection becomes excessively aggressive, leading to organ damage. This overreaction can be fatal, with over 1.7 million adults in the U.S. developing sepsis each year, and a mortality rate exceeding 270,000 annually. The condition requires immediate medical attention, similar to the urgency needed for a stroke or heart attack. Sepsis is also the leading cause of hospital readmission and incurs significant healthcare costs, with an estimated annual expenditure of $62 billion for acute sepsis hospitalization and skilled nursing.

The COVID-19 pandemic has heightened awareness of sepsis, as it disproportionately affects those with pre-existing conditions. Current treatments focus on managing the symptoms, but there is a growing interest in therapies that target the dysregulated immune response, which is at the heart of sepsis. Despite treatments, the disease remains the third leading cause of death in hospitals, after heart disease and cancer, with a mortality rate of approximately 30% for severe cases.

Furthermore, a significant number of sepsis survivors, up to 50%, endure post-sepsis syndrome, which includes new chronic disorders and exacerbation of existing conditions, severely impacting their quality of life. Many survivors are unable to return to work post-recovery, emphasizing the importance of early detection and treatment.

Enlivex Therapeutics Ltd. is at the forefront of addressing this medical challenge by developing a universal cell therapy called AllocetraTM. This therapy aims to reprogram macrophages, immune cells that are often reprogrammed out of their normal state in diseases like sepsis and osteoarthritis, contributing to disease severity. AllocetraTM is designed to reset these macrophages to their normal state, which is crucial for rebalancing the immune system and potentially resolving life-threatening conditions such as sepsis.

The therapy is being developed as an adjunctive treatment to prevent organ failure and reduce mortality in sepsis patients, in addition to standard care like antibiotics and vasopressors. Enlivex has recently completed the enrollment of 120 patients in a phase 2 trial for AllocetraTM. This trial is a blinded, placebo-controlled, randomized, multi-country, multi-center study that assesses the efficacy of AllocetraTM in patients with moderate to severe sepsis caused by various infections.

Einat Galamidi, Medical Vice President of Enlivex, has expressed the significance of this milestone in the phase 2 trial, stating that the top-line data is expected to be reported by the end of the first quarter of 2024. The company acknowledges the dedication of the investigators and the patients involved in the trial, which is a crucial step towards potentially revolutionizing the treatment of sepsis and addressing this significant unmet medical need.