Enlivex: After Review of Phase II Data, Israeli Ministry of Health Authorizes Initiation of a Multi-Center, Randomized Phase IIb Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients

Rhea-AI Summary

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has received authorization from the Israeli Ministry of Health to initiate a Phase IIb clinical trial of Allocetra^TM for severe COVID-19 patients with ARDS. The trial will enroll up to 152 patients across Israel and Europe, focusing on safety and efficacy alongside standard treatment. Previous trials showed Allocetra^TM achieved a 0% mortality rate and 90.5% recovery in severe cases within 28 days. The Phase IIb trial aims to evaluate ventilation-free survival and long-COVID symptoms.

Positive

• Authorization received for Phase IIb trial of Allocetra^TM in severe COVID-19 patients.
• Previous trials reported a 0% mortality rate and 90.5% recovery in 28 days.
• Trial designed to evaluate safety and efficacy in a larger patient group.

Negative

• None.

Nes Ziona, Israel, Aug. 15, 2021 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today reported that after reviewing previously-reported Phase II trial data, the Israeli Ministry of Health has authorized the initiation of a proposed Company-sponsored, multi-center, placebo-controlled, randomized, blinded, Phase IIb clinical trial evaluating Allocetra^TM in severe and critical COVID-19 patients with acute respiratory distressed syndrome (ARDS).

The Phase IIb trial is expected to recruit up to 152 severe or critical COVID-19 patients in clinical centers in Israel and certain European countries, and is designed to assess the safety and efficacy of Allocetra^TM when administered in addition to standard of care treatment.

Enlivex previously reported positive top-line results from Phase Ib and Phase II investigator-initiated clinical trials of Allocetra^TM in COVID-19 patients in severe and critical condition. Aggregate data from the two trials demonstrated that Allocetra^TM was safe and well tolerated. Moreover, at the end of the 28-day follow-up period, a 0% (0/21) mortality rate was observed and 90.5% (19/21) of patients recovered from their respective severe/critical condition and were discharged from the hospital after an average of 5.6 days following Allocetra^TM administration.

The planned Phase IIb clinical trial will have two primary endpoints: ventilation-free survival and recovery for each of the two sub-populations of patients in the study (severe and critical). In addition, the trial will assess several secondary endpoints, including evaluation of long-COVID-19 symptoms.

Oren Hershkovitz, Ph.D., CEO of Enlivex, and Prof. Dror Mevorach, Chief Scientific Officer of Enlivex, stated in a joint comment: “We would like to thank the Israeli Ministry of Health for the expedited review and for authorizing a Phase IIb clinical trial of Allocetra^TM in COVID-19 patients in severe and critical condition.”

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 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, the expected timing of clinical trials’ results for, and market opportunities for, ALLOCETRA^TM programs, as well as potential changes in the severity level of the COVID-19 pandemic (including due to new variants of the virus) and the effect of such changes on pace of patient recruitment into clinical trials, manufacturing delays, and changes in market opportunities. 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 be delayed and/or 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 purpose of the Phase IIb trial for Allocetra^TM?

The Phase IIb trial aims to evaluate the safety and efficacy of Allocetra^TM in severe COVID-19 patients with ARDS.

How many patients will be enrolled in the Phase IIb trial of Allocetra^TM?

The trial plans to recruit up to 152 severe or critical COVID-19 patients.

What were the results of previous trials for Allocetra^TM?

Previous trials showed a 0% mortality rate and 90.5% recovery for patients treated with Allocetra^TM within 28 days.

When does the Phase IIb trial for Allocetra^TM start?

The Phase IIb trial is authorized to start following the recent approval by the Israeli Ministry of Health.

What are the primary endpoints of the Phase IIb trial?

The primary endpoints are ventilation-free survival and recovery rates for severe and critical patients.