Enlivex Receives Authorization from the Danish Medicines Agency to Initiate the Phase II Stage of its Phase I/II Trial of Allocetra in Patients with Moderate to Severe Knee Osteoarthritis
September 26 2024 - 8:30AM
Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a
clinical-stage macrophage reprogramming immunotherapy company,
today announced that the Danish Medicines Agency authorized the
initiation of the Phase II stage of the Company’s multi-country
Phase I/II trial in moderate and severe knee osteoarthritis.
This approval follows the recently announced recommendation
by the independent Data and Safety Monitoring Board (DSMB) that the
Company may move forward to the Phase II stage of the trial.
The Phase I/II multi-center clinical trial is composed of two
stages. The first stage is a Phase I safety run-in, open-label dose
escalation phase to characterize the safety and tolerability of
Allocetra™ injections to the target knee in order to identify the
dose and injection regimen for the subsequent Phase II stage. The
Phase II stage is a double-blind, randomized, placebo-controlled
stage, which the Company is now initiating following the completion
of the safety run-in stage and the safety confirmation by the DSMB,
which the Company recently announced. In addition to evaluating
safety, the blinded randomized stage is statistically-powered to
assess the efficacy of Allocetra™ injections into the knee. The
Company expects that the primary measurements will evaluate
joint-pain and joint-function in comparison to placebo at three
months, six months and 12 months after treatment.
Einat Galamidi, MD, Medical Vice President of Enlivex,
commented, “We are pleased with the safety profile of Allocetra™
following three sequential intra-articular knee injections, as
demonstrated in the first twelve patients in the Phase I safety
run-in stage of this trial, and the approval to progress into the
double-blind, randomized, placebo controlled Phase II stage.”
ABOUT KNEE OSTEOARTHRITIS1
Osteoarthritis is by far the most common form of arthritis,
affecting more than 32.5 million Americans and more than 300
million individuals worldwide. About half of knees with ACL
injuries develop osteoarthritis within 5 to 15 years. 78 million
Americans are projected to have osteoarthritis by the year 2040.
Symptomatic knee osteoarthritis is particularly prevalent and
disabling, with 40% of men and 47% of women developing knee
osteoarthritis in their lifetimes. Osteoarthritis accounts for over
one million hospitalizations annually in the United States,
primarily for total joint replacement. The burden of osteoarthritis
is enormous, and the need for treatments that reduce pain and
attendant disability for persons with osteoarthritis is critical.
There are currently no medications approved by either the U.S. Food
and Drug Administration (FDA) or the European Medicines Agency
(EMA) that have been demonstrated to arrest, slow or reverse
progression of structural damage in the joint.
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 and life debilitating
conditions. For more information,
visit https://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 CONTACTShachar Shlosberger, CFOEnlivex
Therapeutics, Ltd.shachar@enlivexpharm.com
INVESTOR RELATIONS CONTACTDave Gentry, CEORedChip
Companies Inc.1-407-644-4256ENLV@redchip.com
_______________
1 Source: The Arthritis Foundation; Disease modification in
osteoarthritis; pathways to drug approval, Katz et. Al.,
Osteoarthritis and Cartilage Open (2) (2020)
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