Full Press Release Details
Enlivex Announces Topline Results of Its Phase II Trial Evaluating Allocetra In Patients With Sepsis
April 11, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming
immunotherapy company, today announced positive indication of effect and safety results from its Phase II study of Allocetra in
patients with sepsis, in which 120 patients enrolled.
Bruno Fran ois, M.D., intensive care physician, is the head of the Limoges
Clinical Investigation Center (Limoges, France). Dr. Fran ois took a primary role in the design of the study, medical support and
oversight of patient eligibility. Dr. Fran ois was the national coordinator for numerous emergency trials, especially in sepsis,
and has participated in several advisory boards for sepsis multinational trials, independent clinical evaluation committees and adjudication
committees. Dr. Fran ois stated, "I am very excited about Allocetra's novel approach, using a first-in-class
innovative cell therapy to explore the treatment of patients with acute, life-threatening sepsis and septic shock. The study, a randomized
controlled trial conducted in six countries and multiple clinical centers, demonstrated a favorable safety profile for Allocetra . Within
the context of the study, we also learned the ease of use and feasibility to infuse Allocetra cells to patients even in the complex
setting of the intensive care unit. The study was well designed and executed, although randomization resulted in the Allocetra - treated cohorts
having higher frequencies of septic shock and invasive ventilation prior to treatment, as compared with the control group. Because these
patient attributes are typically associated with a significantly higher degree of difficulty of treatment and higher mortality rates,
the relative effect of Allocetra in some patient sub populations was challenging to deduce. I am pleased with the unusually low
mortality rates across the board in the study, and that Allocetra demonstrated a potential indication of effect in high-risk sepsis
patients originating from urinary tract infections. A substantial number of sepsis cases originate from urinary tract infections, and
we have been actively searching for additional treatment alternatives for those patients, especially those who are at high risk. Having
reviewed the topline study results, I look forward to reviewing the forthcoming additional safety and biomarker data of patients in the
study, and I recommend the further exploration of the use of Allocetra in the High Risk UTI population."
Ph.D., CEO of Enlivex said, "We are pleased with the demonstration of substantial SOFA score reductions and low mortality rate of
the Allocetra -treated patients across all origins of sepsis in the study, the indication of effect compared with placebo for the
high-risk patients whose sepsis originated from urinary tract infections, and the favorable safety profile of Allocetra . The Company
intends to consider, upon reviewing the totality of the data, a potential follow-on, randomized, controlled study of a solely High Risk
UTI sepsis population. Up to 31% of sepsis cases start as UTIs4, and this represents a substantial potential market opportunity for Allocetra .
The randomization resulted in the Allocetra -treated cohorts having 20% higher frequency of septic shock and 35% higher frequency of invasive
ventilation prior to treatment, compared with the placebo group. Both of these patient attributes are associated with significantly higher
degree of difficulty of treatment and higher mortality rates, and potentially resulted in patients with more severe sepsis in the Allocetra -treated
cohorts. These biases made it challenging to deduce the relative effect in other patient subgroups."
Urinary tract infection (UTI) is the second most common infectious disease affecting more than
150 million people globally annually. Up to 31% of sepsis cases start as UTIs, representing up to 9.8 million cases in the United States
and Europe, leading to as many as 1.6 million deaths4.
ABOUT THE PHASE II SEPSIS CLINICAL TRIAL (NCT# NCT04612413)
The Phase II trial was a placebo-controlled, randomized,
dose-finding, multi-country, multi-center study, evaluating frozen-formulation Allocetra in addition to standard of care in patients
with sepsis associated with pneumonia, biliary, urinary tract, or peritoneal infections. The results contained in this press release represent
topline data and are subject to revision based on the ongoing collection of study information and detailed analysis. The Company expects
to release further details about the study in a forthcoming presentation.
Allocetra 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, 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 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.
Enlivex is a clinical stage macrophage reprogramming immunotherapy
company developing Allocetra , 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
debilitating and 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 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 ALLOCETRATM
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.
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.