NES-ZIONA, Israel - Enlivex Therapeutics Ltd. (NASDAQ:ENLV), a clinical-stage immunotherapy company, today announced results from its Phase II clinical trial evaluating Allocetra™ in sepsis patients. The study indicated a reduction in Sequential Organ Failure Assessment (SOFA) scores and a 65% decrease in mortality rates among treated patients compared to expected outcomes.
The trial, involving 120 patients with sepsis, was a randomized controlled study conducted across six countries. It specifically noted a 90% reduction in SOFA scores for sepsis patients with urinary tract infections, a 68% reduction for those with community-acquired pneumonia, and a 36% reduction for internal abdominal infections.
Despite the Allocetra™-treated group having a 20% higher incidence of septic shock and a 35% higher need for invasive ventilation at the outset, the treatment showed a favorable safety profile. These factors typically predict a more difficult treatment course and higher mortality, complicating the assessment of Allocetra's™ relative effect in various patient subgroups.
Dr. Bruno François, an intensive care physician involved in the study's design and execution, expressed optimism about Allocetra's™ innovative approach and recommended further exploration of its use, especially in high-risk urinary tract infection-derived sepsis cases.
Enlivex plans to review the complete data set before potentially pursuing a follow-on study focused on this high-risk patient population. The company's CEO, Dr. Oren Hershkovitz, highlighted the significant market opportunity, with up to 31% of sepsis cases beginning as urinary tract infections in the United States and Europe.
Allocetra™ is being developed as an off-the-shelf cell therapy to reprogram macrophages to a homeostatic state, aiming to rebalance the immune system and address life-threatening conditions. Further details on the study are expected in an upcoming presentation.
This report is based on a press release statement from Enlivex Therapeutics Ltd.
InvestingPro Insights
Following the promising results of Enlivex Therapeutics Ltd.'s (NASDAQ:ENLV) Phase II clinical trial, investors may be keen on understanding the financial health and market performance of the company. According to recent metrics from InvestingPro, Enlivex holds a market capitalization of 74.02 million USD, reflecting its size and investor expectations within the biotechnology sector. With a Price to Earnings (P/E) Ratio for the last twelve months as of Q4 2023 at -2.92, the company is currently not profitable, a common scenario for clinical-stage biotech companies investing heavily in research and development.
InvestingPro Tips suggest that while Enlivex holds more cash than debt on its balance sheet, which is a positive sign of financial stability, the company is quickly burning through cash due to its operational activities. A significant return over the last week of 9.04% and a strong return over the last three months of 35.76% could indicate growing investor confidence following recent developments. However, analysts do not anticipate the company will be profitable this year, which is an important consideration for potential investors.
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