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Enlivex Therapeutics Stock (NASDAQ:ENLV) plunged 50% in morning trading Thursday after the company reported bias issues in a Phase 2 study of its cell therapy product Allocetra in the treatment of sepsis.
The study evaluated the product in patients with sepsis resulting from community-acquired pneumonia, internal abdominal infections or urinary tract infections, also known as UTIs.
The Israeli company said that after reviewing the entirety of the data, it intends to consider conducting a follow-up, randomized, controlled study only of patients with high-risk UTI sepsis, which represents a “potential market opportunity.” substantial for Allocetra. He noted that up to 31% of sepsis cases begin as a UTI.
“Randomization resulted in the Allocetra-treated cohorts having a 20% higher frequency of septic shock and a 35% higher frequency of invasive ventilation before treatment, compared to the placebo group,” said the CEO of Enlivex, Oren Hershkovitz, in a statement about the study. “These biases made it difficult to deduce the relative effect in other patient subgroups.”
