02:14 PM EDT, 04/11/2024 (MT Newswires) -- Enlivex Therapeutics ( ENLV ) shares fell 55% in recent Thursday trading activity after the company released topline data from a phase 2 trial of Allocetra, an off-the-shelf treatment candidate of sepsis.
The placebo-controlled study evaluated frozen-formulation Allocetra in addition to standard of care in patients with sepsis associated with pneumonia, biliary, urinary tract, or peritoneal infections, the company said.
"The randomization resulted in the Allocetra-treated cohorts having 20% higher frequency of septic shock and 35% higher frequency of invasive ventilation prior to treatment, compared with the placebo group," Enlivex Chief Executive Oren Hershkovitz said.
These attributes are linked with a higher level of treatment difficulty and mortality rates, and "potentially resulted in patients with more severe sepsis in the Allocetra-treated cohorts" Hershkovitz said, adding that "these biases made it challenging to deduce the relative effect in other patient subgroups."
Stand-alone and placebo-compared analysis of Allocetra IV infusions across all patient groups showed acceptable safety and tolerability, the company said.
Price: 1.79, Change: -2.19, Percent Change: -55.01