Enlivex Therapeutics’ cell therapy has disappointed investors because its impact in a mid-stage test in sepsis was difficult to figure out. The company nonetheless said its candidate could have potential in sepsis specifically due to urinary tract infection.
The Israel-based company is studying its off-the-shelf cell therapy designed to restore macrophage homeostasis. In sepsis, macrophages are reprogrammed out of their homeostatic state, contributing to disease severity, Enlivex said.
The Phase 2 trial tested the cell therapy plus standard of care against placebo in patients with sepsis due to pneumonia, biliary, urinary tract or peritoneal infections, per a Thursday release.
Compared with placebo, patients in the treatment arm had a 20% higher frequency of septic shock and a 35% higher frequency of invasive ventilation before treatment began. “These biases made it challenging to deduce the relative effect in other patient subgroups,” CEO Oren Hershkovitz said in a statement.
Oren HershkovitzNonetheless, the treatment achieved “substantial reductions” in the primary endpoint of change in sequential organ failure assessment (SOFA) score, including a 90% reduction in the UTI cohort at 28 days, although p-values were not disclosed. The cell therapy was also linked with a 65% reduction in overall mortality rate compared with expected mortality.
The company’s stock $ENLV dropped 54% to close at $1.83 on Thursday.
The company will “consider” a randomized study of the cell therapy in the high-risk UTI sepsis population. Up to 31% of sepsis cases start as UTIs, totaling up to 9.8 million cases in the US and Europe and offering a “substantial potential market opportunity,” Enlivex said.
In September 2023, the company stopped work on its oncology programs and laid off 50% of its workforce as it shifted attention toward inflammatory and autoimmune diseases. At the time, Enlivex said it would seek partnerships and other external opportunities for its cancer assets.