Enlivex Announces Completion of Enrollment of Its Phase II Trial Evaluating Allocetra In Patients With Sepsis
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Insights
The completion of patient enrollment in Enlivex Therapeutics Ltd.'s Phase II trial for Allocetra™ marks a significant juncture in the clinical development of this immunotherapy treatment for sepsis. As sepsis remains a condition with high mortality and limited treatment options, the advancement of Allocetra™ through clinical trials is noteworthy. The study's design, which is placebo-controlled and randomized, aims to provide robust data on the efficacy and optimal dosing of the drug.
From an investment perspective, the progress of this trial is a critical indicator of the company's potential to bring a new therapy to market. The anticipation of top-line data by the end of Q1 2024 will likely be a focal point for investors, as positive results could signify a breakthrough in sepsis treatment and potentially lead to a surge in the company's valuation. Conversely, if the results are not favorable, the company may face setbacks both in development and stock performance.
Allocetra™ represents a unique approach to treating sepsis by reprogramming macrophages, which are cells involved in the immune response. Given the current absence of FDA-approved therapies specifically for sepsis, Allocetra™, if successful, could meet a significant unmet medical need. This has implications for healthcare providers, payers and patients, potentially altering the standard of care and reducing the substantial morbidity and mortality associated with sepsis.
The economic burden of sepsis is considerable, with implications for healthcare spending and resource allocation. A successful treatment could lead to cost savings for healthcare systems and improvement in patient outcomes. For stakeholders, the progress of this trial is a critical watch-point, as it could signal a forthcoming change in the treatment landscape for a condition that affects over 1.7 million adults in the U.S. annually.
The biotechnology sector is highly sensitive to clinical trial outcomes, which can have immediate and significant impacts on a company's stock price. The announcement of completed enrollment in Enlivex's Phase II study is a positive operational update, but it is the pending top-line data that will be the true catalyst for stock movement. Investors will be closely monitoring this event, as positive data could lead to increased investor confidence and potential partnerships or funding opportunities for Enlivex.
Moreover, the company's ability to meet its enrollment timeline reflects on its operational efficiency and may influence investor perception of management's competency. The multi-country, multi-center nature of the study also suggests a strategic approach to facilitate broader regulatory approval and market access upon successful trial outcomes. The financial implications of Allocetra™'s success are significant, considering the high costs associated with sepsis management and the potential market size.
- Enrollment completed in placebo-controlled, randomized, dose-finding, multi-country, multi-center Phase II sepsis study
- Topline Data Expected in late Q1 2024
Nes-Ziona, Israel, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Company completed enrollment of all 120 patients in its Phase II trial of Allocetra™ in patients with sepsis.
The Phase II trial is 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. Sepsis is a life-threatening disease with no therapies approved by the U.S. Food and Drug Administration and a high unmet need. Each year, more than 1.7 million adults in the United States develop sepsis, with annual mortality of more than 270,000 due to the disease.
“The completion of the enrollment in our Phase II trial of Allocetra™ in patients with sepsis is an important execution milestone for Enlivex, meeting our enrollment timeline” stated Einat Galamidi, Medical Vice President of Enlivex. “We expect, in line with our prior timeline guidance, to report the top-line data readout from the trial by the end of Q1 2024. We appreciate the hard work of the investigators involved in this trial across multiple medical centers, and the patients who have helped us achieve this key milestone.”
ABOUT ALLOCETRA™
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.
ABOUT ENLIVEX
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 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, ALLOCETRATM 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.
ENLIVEX CONTACT
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.
shachar@enlivexpharm.com
INVESTOR RELATIONS CONTACT
Eric Ribner
LifeSci Advisors
eric@lifesciadvisors.com
FAQ
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