Enlivex Receives Regulatory Authorization to Expand its Phase IIb Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients into Greece

Rhea-AI Summary

Enlivex Therapeutics Ltd. announced that Greece’s National Organization of Medicines has approved the expansion of its Phase IIb trial for Allocetra^TM in severe COVID-19 patients to additional sites. The trial aims to enroll up to 152 patients and assess the drug's safety and efficacy alongside standard treatment. Previously reported trials indicated a 0% mortality rate and a 90.5% recovery rate in severe cases. Top-line data is anticipated in late 2022 or Q1 2023. The company aims to expand its clinical trials throughout Europe.

Positive

• Expansion of Phase IIb trial into Greece and Spain, increasing patient enrollment opportunities.
• Previous trials showed a 0% mortality rate and 90.5% recovery rate after 28 days.

Negative

• No guidance provided for potential emergency or conditional marketing authorization.
• Top-line data from the trial is not expected until late 2022 or Q1 2023, leading to uncertainty.

Nes-Ziona, Israel, Dec. 13, 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 IIb trial evaluating Allocetra^TM in severe and critical COVID-19 patients with acute respiratory distress syndrome (ARDS) to sites in the country.

The placebo-controlled trial, which is currently enrolling patients at clinical trial sites in Israel and was recently cleared to expand into Spain, is expected to recruit up to 152 severe or critical COVID-19 patients. It is designed to assess the safety and efficacy of Allocetra^TM when administered in addition to standard-of-care treatment. The trial's two primary endpoints are ventilation-free survival and recovery for each of the two sub-populations of patients in the study (severe and critical), and could potentially be sufficient for obtaining emergency or conditional marketing authorization for either patient sub-population, though no guidance as to the potential for such emergency or conditional marketing authorization has been provided by the Israeli Ministry of Health or European regulators. Enlivex currently expects that top-line data from the trial will be available in late 2022 or Q1 of 2023.

The ongoing Phase IIb trial is supported by previously reported positive 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.

Oren Hershkovitz, Ph.D., CEO of Enlivex, commented, “This latest authorization to expand the geographic reach of one of our clinical trials provides yet another example of our team’s ability to successfully execute on our regulatory strategy. Looking ahead, we expect the strength of our data and the rigor of our study design and manufacturing process to continue to serve us well as we work to further expand our trials 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 did Enlivex announce on December 13, 2021?

Enlivex announced the expansion of its Phase IIb clinical trial for Allocetra^TM in severe COVID-19 patients to Greece.

What are the main endpoints of the Allocetra^TM trial?

The trial's primary endpoints are ventilation-free survival and recovery of patients.

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

Previous trials demonstrated a 0% mortality rate and a 90.5% recovery rate after 28 days.

When can we expect top-line data from the Allocetra^TM trial?

Top-line data is expected to be available in late 2022 or Q1 of 2023.

What is the stock symbol for Enlivex Therapeutics?

The stock symbol for Enlivex Therapeutics is ENLV.