Enlivex Therapeutics gets Israeli MoH approval for Phase I sepsis trial
Ticker: ENLV · Form: 6-K · Filed: Dec 11, 2024 · CIK: 1596812
Sentiment: neutral
Topics: clinical-trial, regulatory-approval, drug-development
TL;DR
Enlivex gets green light from Israeli MoH for Phase I sepsis trial on Allocetra.
AI Summary
On December 11, 2024, Enlivex Therapeutics Ltd. announced that the Israeli Ministry of Health has authorized the initiation of a Phase I investigator-initiated trial. This trial will evaluate the safety and tolerability of Allocetra, Enlivex's lead drug candidate, in patients with severe sepsis.
Why It Matters
This approval marks a significant step for Enlivex as it allows them to begin clinical evaluation of their lead drug candidate, Allocetra, in a new indication, potentially opening up a large market.
Risk Assessment
Risk Level: medium — Phase I trials are early-stage and carry inherent risks of failure to demonstrate safety or efficacy, and regulatory approvals are not guaranteed.
Key Players & Entities
- Enlivex Therapeutics Ltd. (company) — Registrant
- Israeli Ministry of Health (company) — Regulatory body
- Allocetra (drug) — Lead drug candidate
- December 11, 2024 (date) — Announcement date
FAQ
What is the primary purpose of the newly authorized Phase I trial?
The trial is designed to evaluate the safety and tolerability of Allocetra in patients with severe sepsis.
Which regulatory body authorized the trial?
The Israeli Ministry of Health authorized the initiation of the trial.
What is the name of Enlivex's lead drug candidate being tested?
The lead drug candidate being tested is Allocetra.
What condition will the patients in the trial have?
The patients in the trial will have severe sepsis.
When was this authorization announced?
The announcement was made on December 11, 2024.
Filing Stats: 232 words · 1 min read · ~1 pages · Grade level 12 · Accepted 2024-12-11 08:33:31
Filing Documents
- ea0224288-6k_enlivex.htm (6-K) — 9KB
- ea0224288ex99-1_enlivex.htm (EX-99.1) — 11KB
- 0001213900-24-107661.txt ( ) — 22KB
SIGNATURES
SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. Enlivex Therapeutics Ltd. (Registrant) By: /s/ Oren Hershkovitz Name: Title: Oren Hershkovitz Chief Executive Officer Date: December 11, 2024