Enlivex Therapeutics Ltd. (NASDAQ:ENLV) announced that Israel, Spain and Greece have cleared amendments to the company’s Phase II trial protocol that will allow the study to enroll more patients. 

The cleared amendments also allow Enlivex to use a newly developed frozen formulation of AllocetraTM — the macrophage reprogramming immunotherapy it’s evaluating as a potential sepsis treatment in the clinical trial. 

The Current Standard Of Care For Sepsis Needs Improvement

That’s because it’s not a pathogen in its own right but an extreme response to an infection the patient already has. That underlying infection can be bacterial, fungal or viral so treating sepsis often starts with identifying the underlying infection and administering the appropriate antibiotic, antimicrobial or antiviral treatment.

This initial treatment, along with intravenous fluids and vasopressors to maintain organ function and blood pressure, forms the current standard of care, but they’re really just a way of keeping the patient alive while their immune system, hopefully, fights the infection causing the sepsis response. 

Enlivex’s Allocetra Is An Immunotherapy That Could Rebalance The Immune Response

Allocetra’s formula uses donor macrophages that have been programmed to send out an “eat me” signal to the host’s macrophages. Once engulfed, the donor cells then reprogram those host macrophages to return to their homeostatic state.

In the preclinical and clinical trials Enlivex has completed so far, that return to homeostasis has resulted in reduced mortality and improved sequential organ failure assessment (SOFA) scores, suggesting that the immunotherapy could help moderate the immune response and protect organs from damage and failure. 

While antimicrobials will still be necessary for fighting the underlying infection, Allocetra’s ability to influence the host’s overactive immune response could become an essential tool for preventing long-term damage and reducing mortality rates. 

The Phase II Clinical Trial Will Include An Expanded Patient Population And A More Shelf-Stable Version Of Allocetra

Initially, the Phase II trial was limited to patients with pneumonia-associated sepsis. With the recent amendments cleared by Israel, Spain and Greece, Enlivex is now able to expand the trial to include patients with sepsis related to biliary, urinary tract and peritoneal infections. 

Enlivex plans to submit these same protocol amendments in other jurisdictions in hopes of further expanding its Phase II research. But with the regulatory clearance achieved so far, the company is optimistic that it can shorten the timeline to potential approval of frozen Allocetra as a sepsis treatment, which could move up the date of a possible commercial launch. 

Featured photo by Alexander Grey on Unsplash

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