Enlivex Receives Regulatory Authorization to Expand its Phase II Sepsis Trial into Greece

Rhea-AI Summary

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced its Phase II trial for Allocetra^TM in pneumonia-associated sepsis has received approval for expansion into Greece. The trial, already active in Israel and Spain, aims to enroll 120 to 160 patients across four cohorts, assessing safety and efficacy over a 28-day follow-up. Previous Phase Ib results indicated a positive safety profile and improved clinical outcomes. Interim results are expected in the first half of 2022, with top-line data anticipated by year-end 2022.

Positive

• Authorization to expand Phase II trial of Allocetra^TM into Greece.
• Previous Phase Ib trial showed positive safety profile and improved clinical outcomes.
• Trial aims to enroll a significant number of patients (120 to 160) to strengthen data.

Negative

• None.

Nes-Ziona, Israel, Dec. 07, 2021 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that, following a review of the Company’s preclinical and clinical data, study design, and manufacturing process, Greece’s National Organization of Medicines has authorized the expansion of the Company’s Phase II trial of Allocetra^TM in patients with pneumonia-associated sepsis to sites in the country.

The placebo-controlled trial, which has multiple sites currently open for enrollment in Israel and was recently cleared to expand into Spain, is expected to enroll 120 to 160 patients across four cohorts receiving varying doses of Allocetra^TM or placebo, all in addition to standard-of-care therapy. The trial's two primary endpoints are safety (number and severity of adverse events and severe adverse events) and efficacy (change from baseline in sequential organ failure (SOFA) score), which will be assessed throughout a 28-day follow-up period. Additionally, the trial’s secondary endpoint is 28-day all-cause mortality. The trial is supported by previously reported positive results from a Phase Ib trial that demonstrated a positive safety profile and vastly improved clinical outcomes, including SOFA scores, duration of hospitalization, and mortality, in Allocetra-treated sepsis patients compared to a group of matched historical controls that received standard-of-care therapy. Interim results from the Phase II trial are expected in the first half of 2022, and top-line data are expected by year-end 2022.  

Oren Hershkovitz, Ph.D., CEO of Enlivex, commented, “Receiving clearance to expand our sepsis trial into Greece is an important accomplishment that we believe demonstrates our ability to efficiently execute on our regulatory strategy. It also underscores the strength of our datasets and the rigor of our study design and manufacturing process. Looking ahead, we will continue our efforts to efficiently advance this trial, including working with additional regulatory agencies to further expand the trial throughout Europe.”

ABOUT ALLOCETRA^TM

Allocetra^TM is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, COVID-19 and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra^TM has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.

ABOUT ENLIVEX

Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra^TM, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. For more information, visit http://www.enlivex.com.

Safe Harbor Statement:  This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would”, “could,” “intends,” “estimates,” “suggests,” “has the potential to” and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRA^TM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRA^TM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties.  In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including in the Company’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission.  The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.

ENLIVEX CONTACT
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.
shachar@enlivexpharm.com

INVESTOR RELATIONS CONTACT
Eric Ribner
LifeSci Advisors
eric@lifesciadvisors.com

FAQ

What is the significance of the Phase II trial expansion for ENLV in Greece?

The expansion indicates regulatory confidence and enhances Enlivex's ability to gather more comprehensive clinical data.

When are the interim results from the Allocetra^TM trial expected for ENLV?

Interim results from the Phase II trial are expected in the first half of 2022.

What are the primary endpoints of the Allocetra^TM trial for ENLV?

The primary endpoints are safety and efficacy, specifically the number and severity of adverse events and changes in sequential organ failure (SOFA) scores.

How many patients will be enrolled in the Allocetra^TM trial for ENLV?

The trial will enroll between 120 to 160 patients.

What are the expected outcomes of the Allocetra^TM trial for ENLV?

Expected outcomes include safety and efficacy of Allocetra^TM in reducing mortality and improving clinical scores.