ARTCLINE has completed patient enrolment in a 142-patient randomized study evaluating its ARTICE therapy for septic shock, with results expected after a 90-day follow-up period later this year.

The German biotech said all patients have now been recruited into the ReActIF-ICE trial, a multicentre controlled study assessing whether donor-derived immune cell therapy can safely support patients whose immune systems have become dysregulated during septic shock.

Data from the study are planned for presentation at the DIVI Congress in Hamburg in December.

Septic shock is the most severe form of sepsis and remains one of the leading causes of death in intensive care medicine. Despite advances in critical care, mortality remains high and treatment options are limited once widespread organ dysfunction develops.

ARTCLINE said the study enrolled patients across 20 intensive care centres. Participants in the treatment arm receive up to six ARTICE treatments over nine days in addition to standard of care, while the control group receives standard treatment alone.

The primary endpoint is safety and tolerability through Day 28, measured by the occurrence of new serious adverse events. Secondary endpoints include mortality at Day 28, Day 90 and hospital discharge, as well as changes in Sequential Organ Failure Assessment scores.

Jens Altrichter, founder and managing director of ARTCLINE, said: “The enrollment of the last patient marks an important milestone for ARTCLINE.”

He added: “With the collection of additional safety and mortality data, we have come a significant step closer to our goal of establishing a new therapeutic option for patients with septic shock.”

The company has not yet released interim efficacy data.

The University Medical Center Rostock was the highest enrolling site, recruiting 31 patients, according to the company. Principal investigator Daniel Reuter said clinicians had gained practical experience using the extracorporeal immune cell treatment during the study.

If successful, the programme could offer a new treatment approach in septic shock, where secondary infections and recurrent organ failure remain major causes of death after the initial acute phase.

Investor and clinical attention is likely to turn to the upcoming data readout, which should determine whether ARTICE can move into later-stage development.