Enlivex Therapeutics (Nasdaq: ENLV) reported today (Wed) that the French Agency for Food, Environment, Health and Occupational Safety (ANSES) and the Belgian Federal Hazards for Medicines and Health Products (FAMHP) approved the revised protocol of the company’s phase II trial to evaluate Allocetra in sepsis patients.
The approved protocol, which has already received approval in Israel, Greece and Spain, allows the treatment of new patients who will be recruited for the trial with the frozen formulation of Allocetra as well as the expansion of the trial population, which was originally limited to sepsis patients as a result of pneumonia, so that it will include patients whose septic condition is due to infections in the biliary tract, urinary tract or in the abdominal cavity.
The phase II trial is expected to include 80-160 patients in 4 groups, who will receive varying doses of Allocetra or placebo, all in combination with the standard of care. The 2 primary trial objectives include safety (number and severity of common and serious side effects) and efficacy (change from baseline in the SOFA system collapse index) after a 28-day follow-up period. The trial is supported by positive results reported from Phase Ib, showing broadly improved clinical outcomes, including SOFA scores, length of hospital stay and mortality rates in sepsis patients treated with Aloetra compared to the group receiving standard care.
Enlivex CEO Dr. Oren Hershkovich stated that “the expansion of the trial to France and Belgium with a frozen formulation of Allocetra is an important step in the implementation of the ongoing Phase II trial in Sepsis. We believe that it also represents a notable regulatory achievement that provides additional validation for the revised trial design to ours and to the frozen formulation of Allocetra”.