Enlivex Reports Positive Top-Line Results from Phase II Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients and Provides a Program Update

Phase II (16 patients treated, 9/16 (56%) with severe illness, 7/16 (44%) with critical illness, follow-up period of 28 days post-AllocetraTM treatment) 0/16 (0%) mortality on day-28 14/16 (87.5%) patients recovered and were discharged from the hospital by day-28 Average duration of hospitalization post administration of AllocetraTM for discharged patients was 5.3 days 2/16 (12.5%) patients, both of whom had critical illness at the time of AllocetraTM treatment, were hospitalized in the ICU on a respirator on day-28 Phase II + Ib (21 patients treated, 11/21 (52%) with severe illness, 10/21 (48%) with critical illness) 0/21 (0%) mortality on day-28 19/21 (90.5%) patients recovered and were discharged from the hospital by day-28 Average duration of hospitalization post administration of AllocetraTM for discharged patients was 5.6 days 2/21 (9.5%) patients, both of whom had critical illness at the time of AllocetraTM treatment, were hospitalized in the ICU on a respirator on day-28 Based on the positive safety and efficacy results from the Phase II trial and in consultation with the trial’s principal investigator, the Company has completed the Phase II trial early after enrolling sixteen, rather than twenty-four, patients. The Company expects to submit a summary of the data to regulatory bodies later this month to serve as the basis for a discussion on the next steps in Allocetra’s regulatory pathway in COVID-19 patients with severe or critical illness. Allocetra’s intrinsic mechanism of action is immune-modulation, and is expected to potentially be relevant to COVID-19 severe/critical patients infected by various coronavirus strain mutations Nes Ziona, Israel, Feb. 03, 2021 — Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, today reported positive top-line results from a multi-center, investigator-initiated Phase II clinical trial evaluating AllocetraTM in severe and critical COVID-19 patients. Based on the positive results and in consultation with the trial’s principal investigator, the Company has completed the trial early and plans to submit a summary of the data for review by the relevant regulatory bodies. Submission of the data summary to regulators is expected later this month and will serve as the basis for a discussion with regulators on the next steps in Allocetra’s regulatory pathway in COVID-19 patients with severe or critical illness.

The release as fetched from its publisher. enlivex.com ↗