Full Press Release Details
Announces Positive Interim Data - Statistically Significant 47.0% Durable and Persistent Pain Reduction At Six Months, in Patients
with Moderate to Severe Knee Osteoarthritis
Israel, March 03, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage
reprogramming immunotherapy company, today announced positive interim six-month efficacy data from the Phase I stage of its randomized, multi-country
Phase I/II Allocetra trial in patients with moderate to severe knee osteoarthritis.
Hershkovitz, Ph.D, CEO of Enlivex, commented, "We are very excited about the 6-month interim results. The substantial and persistent
pain reduction in these patients following AllocetraTM treatment is extremely important. We believe patients with moderate
to severe knee osteoarthritis seek treatment offering an immediate, durable and marked improvement in their pain and function, and we
believe these results, together with our previously reported Phase I interim results of patients measured three months following the
administration of Allocetra injections, demonstrate the potential for Allocetra to be such a treatment. Our recruitment
efforts for the Phase II stage of this trial are going according to plan, and we remain fully committed to assessing Allocetra's
novel mechanism of action as a treatment alternative for patients with moderate to severe knee osteoarthritis."
The multi-center Phase I/II clinical trial consists of
two stages. The first stage, which was successfully completed, was 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 described below. This second stage is progressing along the previously announced timeline, and the Company
currently expects a topline data readout from the Phase I/II trial by the third quarter of 2025.
The Company previously announced positive 3-month
interim safety and efficacy results for the first 12 patients treated in the Phase I stage. The previously announced data demonstrated
a marked statistically significant improvements in all key efficacy endpoints, including 50%1
average pain reduction and 42% and 37% improvement in functionality and stiffness, respectively, compared to the baseline2.
All 12 patients in the Phase I stage completed the assessment at 6 months following the last injection3,
and the data from such assessments showed a statistically significant 47.0% average reduction of reported pain (P=0.0001), compared to
the pain level at baseline. The reported reduction in pain was consistent with the data from the WOMAC questionnaire used to assess function
and stiffness, in addition to pain, which showed a 51.2% reduction in the WOMAC pain, a 46% improvement in WOMAC function and a 40% improvement
in WOMAC stiffness. Similar to the 3-month interim analysis for the Phase I data, 83% of the patients were still considered as responders
to treatment4. The 6-month interim results have remained consistent with the results
reported at 3 months, indicating a durable and substantial improvement in pain and functional capacity up to 6 months following the last
injection. Safety profile of Allocetra was also consistent with previous report as well, with no serious adverse events while
transient events of discomfort/pain or swelling in the knee following injection were reported, mostly mild in severity.
The trial is currently enrolling patients into the Phase II
stage, which is a double-blind, randomized, placebo-controlled trial. In addition to evaluating safety, this blinded randomized second
stage is statistically powered to assess the efficacy of Allocetra injections into the knee. The trial's key efficacy end
points will evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months post treatment.
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.
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/.
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, expected
clinical trial results, 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 Therapeutics, Ltd.
RedChip Companies Inc.