Spanish Regulator Grants Enlivex Authorization To Expand Its Sepsis Phase II into Spain

Rhea-AI Summary

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced that the Spanish Agency of Medicines and Medical Devices (AEMPS) has approved the expansion of its Phase II trial of Allocetra^TM to clinical sites in Spain. The trial aims to enroll 120 to 160 patients with pneumonia-associated sepsis. It will assess the safety and efficacy of Allocetra^TM compared to a placebo. Previous positive results from a Phase Ib trial indicate significant improvements in clinical outcomes for sepsis patients treated with Allocetra^TM.

Positive

• Approval for Phase II trial expansion to Spain is a significant regulatory achievement.
• Previous Phase Ib trial results showed improved clinical outcomes in sepsis patients treated with Allocetra^TM.

Negative

• None.

Nes Ziona, Israel, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Spanish Agency of Medicines and Medical Devices (AEMPS) has authorized the expansion to clinical sites in Spain of the Company's multi-center, placebo-controlled, randomized, dose-finding, Phase II trial of Allocetra^TM in patients with pneumonia-associated sepsis.

The Phase II trial, which has multiple sites open for enrollment in Israel, is expected to include 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) assessments throughout a 28-day follow-up period. The trial is supported by previously reported positive results from a Phase Ib investigator-initiated trial, showing vastly improved clinical outcomes, including SOFA scores, duration of hospitalization, and mortality, in Allocetra^TM-treated sepsis patients, as compared to a group of matched historical controls who received standard-of-care therapy.

Oren Hershkovitz, Ph.D., CEO of Enlivex, commented, “Receiving authorization to expand our sepsis trial to Spain is an important first step in our broader plan to include several European countries as part of our ongoing clinical trials. We believe this also represents a notable regulatory achievement that provides additional validation for our study design and Allocetra’s manufacturing process, which was reviewed by the Spanish regulator as part of its review process. We would like to thank AEMPS for their review and look forward to the continued advancement of our sepsis program across both Europe and Israel.”

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 recent approval did Enlivex Therapeutics receive regarding Allocetra?

Enlivex Therapeutics received approval from the Spanish AEMPS to expand its Phase II trial of Allocetra^TM to Spain.

What is the focus of the Phase II trial for Allocetra?

The Phase II trial focuses on patients with pneumonia-associated sepsis, assessing the safety and efficacy of Allocetra^TM.

How many patients are expected to be enrolled in the Allocetra trial?

The trial is expected to enroll between 120 to 160 patients across four cohorts.

What were the outcomes of the previous Phase Ib trial for Allocetra?

The previous Phase Ib trial showed vastly improved clinical outcomes, including better SOFA scores and reduced hospitalization duration for treated sepsis patients.