Enlivex Reaffirms August 18, 2025 As Target Date For Announcement of Phase II Topline Data

Rhea-AI Summary

Enlivex Therapeutics (NASDAQ:ENLV) has confirmed the target date of August 18, 2025 for announcing topline data from its Phase II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis. The trial has completed the three-month follow-up period for all 134 patients, marking a significant milestone in the study.

The Phase I/II trial consists of two stages: a Phase I safety run-in, open-label dose escalation phase, followed by a Phase IIa double-blind, randomized, placebo-controlled multi-centered trial. The study's key endpoints include safety assessment and measurement of changes in knee pain and function at three, six, and twelve months post-treatment.

Positive

• None.

Negative

• Results are still pending and success is not guaranteed
• Additional enrollment of up to 50 patients may be needed based on interim evaluation

Insights

Biotechnology Research Analyst

Enlivex's Phase II knee osteoarthritis trial has completed primary endpoint follow-up with results expected August 18, potentially revealing Allocetra's clinical value.

Enlivex has confirmed that all 134 patients in their Phase II knee osteoarthritis trial of Allocetra™ have completed the critical three-month follow-up period. This milestone triggers the final data analysis phase before the company's planned August 18th release of topline results, which will evaluate both safety and efficacy through changes in knee pain and function from baseline.

The study design is particularly robust, featuring a randomized, double-blind, placebo-controlled structure across multiple centers. This methodology substantially increases the reliability of any potential efficacy signals compared to open-label studies. The two-stage approach—beginning with a Phase I safety run-in followed by the current Phase II efficacy evaluation—represents a methodical development pathway for Allocetra™ in this indication.

What's especially noteworthy is the trial's interim statistical evaluation mechanism, conducted by independent third parties while maintaining blinding. This design element allows for potential sample size adjustment (up to 50 additional patients beyond the original 130) based on statistical power calculations. This adaptive approach demonstrates sophisticated trial design aimed at efficiently identifying responder populations—a crucial factor in osteoarthritis, which typically presents with significant patient heterogeneity.

The upcoming results will provide critical insight into Allocetra's potential in moderate to severe knee osteoarthritis, a condition with substantial unmet medical need affecting millions globally. The trial's multiple assessment timepoints (3, 6, and 12 months) will help establish not just immediate efficacy but also durability of response—a key consideration for chronic conditions like osteoarthritis where sustained symptom relief is paramount.

Nes-Ziona, Israel, July 28, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that all 134 patients in its Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis, have completed a follow-up period of at least three months, the trial’s primary timepoint for measurement of key endpoints. The data are being analyzed and audited, with a target date of August 18, 2025 for the public release of audited topline results for three-month key endpoints, including safety and change from baseline in knee pain and function.  

The multi-center Phase I/II clinical trial consists of two stages. The first stage 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 or the subsequent Phase IIa stage. This stage is a double-blind, randomized, placebo-controlled multi-centered trial. In addition to evaluating safety, the study protocol is designed to efficiently find a strong signal in a responder population to guide future development, and includes an interim statistical evaluation, conducted by an independent third party and blinded to the Company, to assess the potential value of enrollment of up to 50 patients in addition to the original randomized sample size of 130, and its marginal impact on the p-value of the statistical estimation of the total group and specifically to identify a potential responder sub-group. The trial’s key efficacy endpoints evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months post treatment.

ABOUT KNEE OSTEOARTHRITIS

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,” “target,” “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

FAQ

When will Enlivex (NASDAQ:ENLV) announce Phase II topline results for Allocetra?

Enlivex plans to announce the topline results on August 18, 2025, which will include safety data and changes in knee pain and function from baseline.

How many patients completed the Phase II trial of Allocetra for knee osteoarthritis?

134 patients have completed the required three-month follow-up period in the Phase II trial.

What are the main endpoints in Enlivex's Phase II Allocetra trial?

The key endpoints include safety assessment and measurement of changes in knee pain and function compared to placebo at three, six, and twelve months post-treatment.

What is the design of Enlivex's Phase I/II Allocetra trial?

The trial consists of two stages: a Phase I safety run-in, open-label dose escalation phase followed by a Phase IIa double-blind, randomized, placebo-controlled multi-centered trial.

How will Enlivex optimize the trial's enrollment?

The trial includes an interim statistical evaluation by an independent third party to assess the potential value of enrolling up to 50 additional patients beyond the original 130-patient sample size.