Enlivex Shares Tumble 50% Amid Mixed Sepsis Therapy Trial Outcomes

Enlivex Therapeutics experienced a significant stock market decline of 50% following the release of mixed outcomes from their Phase II study of the cell therapy Allocetra, which is used for sepsis treatment. The study involved patients with sepsis from pneumonia, internal abdomen, and urinary tract infections, where Allocetra was administered alongside standard care.

A specific analysis indicated that Allocetra could reduce the overall mortality rate by 65% compared to the expected rate. However, the patient randomization process introduced certain biases that complicated the interpretation of the results. The group treated with Allocetra had a 20% higher incidence of septic shock and a 35% higher rate of invasive ventilation prior to treatment, factors that are linked to more severe treatment challenges and higher mortality rates.

Enlivex's CEO, Oren Hershkovitz, highlighted that these biases could have skewed the results, making it difficult to determine the therapy's impact on other patient groups. The therapy showed the most promise in the urinary tract infection group, with a 90% reduction in the sequential organ failure assessment (SOFA) score at 28 days. Patients with pneumonia-related sepsis saw a 68% reduction in their SOFA scores, while those with internal abdomen infections had a 36% reduction.

The Israeli biotech firm is contemplating a follow-up study that would focus exclusively on high-risk urinary tract infection patients. It is noted that up to a third of sepsis cases originate from urinary tract infections, leading to approximately 1.6 million deaths in the U.S. and Europe.

Allocetra is an innovative off-the-shelf cell therapy that aims to reprogram macrophages, a type of white blood cell integral to the body's cleanup process, back to their original state. Diseases such as solid cancers and sepsis can cause these cells to deviate from this state, exacerbating the severity of the disease.

In September 2023, Enlivex decided to halt the development of Allocetra for oncology due to new FDA guidelines that could prolong the clinical development process. The company chose to concentrate on inflammatory and autoimmune indications and made the difficult decision to reduce its workforce by 50% to extend its financial resources until the end of 2025.

The company's focus on refining and advancing its cell therapy in response to the study's findings reflects a commitment to addressing the complex challenges of sepsis treatment and the potential to save many lives through innovative medical solutions.