Enlivex Announces Issuance of New Patent Application Covering the Use of Allocetra in Patients with Osteoarthritis

Rhea-AI Summary

Enlivex Therapeutics (NASDAQ:ENLV) has secured an Israeli patent (No. 290470) for using Allocetra™ to treat osteoarthritis patients, extending protection through 2040. The company recently reported promising Phase IIa results showing significant improvements in knee osteoarthritis patients, including:

• 24% reduction in knee pain and 26% improvement in knee function in the overall modified intention-to-treat population
• 72% reduction in knee pain and 109% improvement in knee function in age-related primary osteoarthritis patients versus placebo

These results demonstrate clinically meaningful and statistically significant effects in common Phase III primary endpoints for knee osteoarthritis trials.

Positive

• Secured new patent protection through 2040 for Allocetra in osteoarthritis treatment
• Phase IIa trial showed 72% reduction in knee pain for age-related osteoarthritis patients
• Demonstrated 109% improvement in knee function for age-related osteoarthritis patients
• Strong results in commonly used Phase III primary endpoints suggest potential for future approval

Negative

• None.

Insights

Biotechnology Patent Analyst

Enlivex secures Israeli patent protection for Allocetra in osteoarthritis through 2040, alongside promising clinical data showing significant pain reduction.

Enlivex's newly issued Israeli patent (290470) provides critical intellectual property protection for Allocetra™ in osteoarthritis treatment until at least 2040. This strategic patent issuance comes at an opportune time, directly following the company's positive Phase IIa results, which demonstrated 24% reduction in knee pain and 26% improvement in knee function in the modified intention-to-treat population compared to placebo.

Most impressive are the results in age-related primary osteoarthritis patients, showing a 72% reduction in knee pain and 109% improvement in knee function versus placebo - effects that qualify as both statistically significant and clinically meaningful for standard Phase III endpoints. The magnitude of these improvements suggests Allocetra™ could potentially address significant unmet needs in osteoarthritis, a condition affecting millions globally with limited effective treatment options.

The CEO's comment about anticipated patent approvals in other major jurisdictions indicates a comprehensive intellectual property strategy. This patent is likely the first in a planned global portfolio designed to maximize commercial protection and market exclusivity for Allocetra™ in osteoarthritis. The extended patent protection through 2040 provides Enlivex substantial runway to commercialize their technology if approved, enhancing the company's long-term value proposition in this therapeutic area.

Clinical Research Specialist

The Phase IIa results for Allocetra™ in knee osteoarthritis represent potentially significant clinical advancements. The 72% pain reduction and 109% function improvement in age-related primary osteoarthritis patients compared to placebo are particularly noteworthy, as these metrics align with primary endpoints commonly used in Phase III trials.

This efficacy differentiation between the overall modified intention-to-treat population (showing 24% pain reduction) and the age-related primary osteoarthritis subgroup suggests Allocetra™ may have specific mechanisms particularly effective in certain osteoarthritis types. This patient stratification could inform future trial designs and potentially lead to more targeted therapeutic applications.

The macrophage reprogramming mechanism of Allocetra™ represents a novel approach to osteoarthritis treatment by addressing underlying inflammatory processes rather than merely treating symptoms. Current osteoarthritis treatments primarily focus on pain management with limited disease-modifying capabilities. If these results are confirmed in larger studies, Allocetra™ could potentially address a significant therapeutic gap for the millions suffering from osteoarthritis with limited effective options. The double-blind, randomized, placebo-controlled trial design also strengthens the validity of these early-stage findings, though larger Phase III studies will be necessary to confirm these promising signals.

Nes-Ziona, Israel, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the issuance of an Israeli patent, numbered 290470, titled, “THERAPEUTIC APOPTOTIC CELLS FOR TREATMENT OF OSTEOARTHRITIS”. The patent will provide Enlivex with added intellectual property protection in Israel through at least 2040 with claims covering methods of using Allocetra™ to treat subjects with osteoarthritis.

Enlivex recently reported positive three-month topline data from the Phase IIa stage of ENX-CL-05-001, a multi-center, two-stage Phase I/II double-blind, randomized, placebo-controlled clinical trial evaluating Allocetra™ in patients with moderate-to-severe knee osteoarthritis.

In the overall modified intention-to-treat (mITT) population, improvements across all efficacy and secondary endpoints, including 24% reduction in knee pain and 26% improvement in knee function, were observed in the Allocetra^TM treatment arm vs placebo; moreover, 72% reduction in knee pain and 109% improvement in knee function were observed for age-related primary osteoarthritis patients compared with placebo – a substantial, clinically meaningful and statistically significant effect in commonly used Phase III primary endpoints for knee osteoarthritis clinical trials.

Oren Hershkovitz, Ph.D, CEO of Enlivex, commented, “We are very pleased to receive another patent issuance for the use of Allocetra^TM as a potential treatment in patients with osteoarthritis. We believe that this issuance provides high assurance that we will be able to obtain similar patents in all major jurisdictions as part of our IP portfolio rollout.”

ABOUT KNEE OSTEOARTHRITIS²

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, expected clinical trial results, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRA^TM 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 ALLOCETRA^TM 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 CONTACT

Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.
shachar@enlivexpharm.com

INVESTOR RELATIONS CONTACT

Dave Gentry, CEO
RedChip Companies Inc.
1-407-644-4256
ENLV@redchip.com

1

According to the OMERACT-OARSI criteria (Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International)

2

Source: The Arthritis Foundation, Disease modification in osteoarthritis; pathways to drug approval, Katz et. Al., Osteoarthritis and Cartilage Open (2) (2020)

FAQ

What are the key findings from Enlivex's (ENLV) Phase IIa trial of Allocetra for osteoarthritis?

The trial showed 24% reduction in knee pain and 26% improvement in knee function in the overall population, with more significant improvements in age-related cases showing 72% pain reduction and 109% function improvement versus placebo.

What patent protection did Enlivex (ENLV) receive for Allocetra in September 2025?

Enlivex received Israeli patent No. 290470 for using Allocetra to treat osteoarthritis patients, providing protection through 2040.

How effective was Allocetra in treating age-related primary osteoarthritis patients?

Allocetra showed substantial efficacy in age-related primary osteoarthritis patients with a 72% reduction in knee pain and 109% improvement in knee function compared to placebo.

What type of clinical trial was conducted for Allocetra in osteoarthritis?

The study (ENX-CL-05-001) was a multi-center, two-stage Phase I/II double-blind, randomized, placebo-controlled clinical trial evaluating Allocetra in patients with moderate-to-severe knee osteoarthritis.