Enlivex Completes Enrollment Of All 120 Patients In Phase 2 Trial Of Allocetra In Patients With Sepsis, Third-Leading Cause Of Mortality In US Hospitals

Mike Williams made a name for himself making difficult endzone catches for the Tampa Bay Buccaneers. Around the corner from the stadium where he once dazzled crowds as a receiver for the NFL team, Williams died in September 2023 at the age of 36. His cause of death was bacterial sepsis. 

A life-threatening emergency, sepsis occurs when the body's response to an infection damages vital organs. This overactive and toxic response can often lead to death, and sepsis is a threatening disease with a high unmet need for treatment. Each year, more than 1.7 million adults in the United States develop sepsis, with annual mortality of more than 270,000 due to the disease.

Similar to a stroke or heart attack, this medical emergency requires swift action when it comes to diagnosis and treatment. Even if it's caught before becoming severe sepsis or septic shock, sepsis is the number one cost of hospitalization in the U.S., with acute sepsis hospitalization and skilled nursing reaching an estimated total of $62 billion annually. 

This is only a portion of all sepsis-related costs. Not only is the average cost per sepsis hospital stay double the average across all other conditions, sepsis is also the primary cause of readmission to the hospital, costing patients more than $3.5 billion each year.

The COVID-19 pandemic increased awareness of sepsis as doctors watched how COVID-19 impacted those with underlying conditions. Treatments today are treating the clinical symptoms associated with sepsis but therapies have been approved by the U.S. Food and Drug Administration that treat the dysregulated immune response, which is the core of the condition. 

Approximately 30% of patients diagnosed with severe sepsis die from the disease, which is the third leading cause of mortality in hospitals, just behind heart disease and cancer. 

Up to 50% of survivors suffer from post-sepsis syndrome, too, reducing their quality of life for years after their diagnosis. New chronic disorders, exacerbation of existing conditions and ailments due to organ failure are common among sepsis survivors. As a result, many people do not return to work after having sepsis.

Until a cure is found, early detection and treatment are essential for the longevity of sepsis survivors. 

Phase 2 Trial

Diseases such as sepsis, osteoarthritis and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. 

Enlivex Therapeutics Ltd. ENLV is developing a universal, off-the-shelf cell therapy, Allocetra^TM, to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions like sepsis. 

Allocetra^TM is being developed as an adjunctive therapy for preventing organ failure and mortality in sepsis, on top of the current standard of care such as antibiotics agents and vasopressors. It could potentially usher in a true paradigm shift in the quest to solve this complex healthcare challenge and unmet medical condition. 

A clinical-stage macrophage reprogramming immunotherapy company, Enlivex has completed enrollment of all 120 patients in its phase 2 trial of Allocetra^TM in patients with sepsis. The phase 2 trial is a blinded, placebo-controlled, randomized, multi-country, multi-center study. It is evaluating frozen-formulation Allocetra^TM in addition to standard of care in patients with moderate to severe sepsis associated with pneumonia, biliary, urinary tract or peritoneal infections. Data from the trial is expected to be released by the end of the quarter. 

“The completion of the enrollment in our phase 2 trial of Allocetra^TM in patients with sepsis is an important execution milestone for Enlivex, meeting our enrollment timeline,” said Einat Galamidi, Medical Vice President of Enlivex. “We expect, in line with our prior timeline guidance, to report the top-line data readout from the trial by the end of Q1 2024. We appreciate the hard work of the investigators involved in this trial across multiple medical centers, and the patients who have helped us achieve this key milestone.”

Featured photo by National Cancer Institute on Unsplash

This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice.