Enlivex Therapeutics ((ENLV)) announced an update on their ongoing clinical study.
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Study Overview: Enlivex Therapeutics is conducting a Phase 2 study titled A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients. The study aims to assess the efficacy, safety, and tolerability of Allocetra-OTS, a novel cell-based therapy, in treating organ failure in sepsis patients. This research is significant as it explores a potential new treatment avenue for sepsis, a condition with high mortality rates.
Intervention/Treatment: The study tests Allocetra-OTS, an immunomodulatory cell-based therapy. It consists of modified allogeneic peripheral blood mononuclear cells designed to be engulfed by macrophages, reprogramming them to a homeostatic state. This intervention aims to improve outcomes in sepsis patients by addressing organ failure.
Study Design: The study is interventional, randomized, and placebo-controlled, with a parallel assignment model. Participants are randomly allocated to one of four groups, including a placebo group and three experimental groups receiving different doses of Allocetra-OTS. The study employs double masking, meaning both participants and investigators are unaware of group assignments, to ensure unbiased results. The primary purpose is treatment-focused.
Study Timeline: The study began on November 30, 2020, and was completed with the last update submitted on August 18, 2025. These dates are crucial as they mark the study’s progression and the availability of the most recent data.
Market Implications: The completion of this study could significantly impact Enlivex Therapeutics’ stock performance and investor sentiment. Positive results may position Allocetra-OTS as a leading treatment for sepsis, potentially increasing the company’s market share. Investors should also consider the competitive landscape, as advancements in sepsis treatment could influence the broader industry.
The study is completed, with further details available on the ClinicalTrials portal.