Enlivex Therapeutics Announces Investor Webinar to Discuss Positive Interim Data from Phase I/II Allocetra™ Trial in Knee Osteoarthritis

Rhea-AI Summary

Enlivex Therapeutics (NASDAQ: ENLV) has announced a webinar to discuss positive interim data from its Phase I/II Allocetra™ trial in knee osteoarthritis patients. The six-month data from the Phase I stage showed significant improvements with:

• 47.0% average reduction in reported pain (P=0.0001)
• 46% improvement in joint function
• 83% of patients maintaining response at six months post-treatment

The results demonstrate Allocetra™'s potential as a breakthrough treatment for moderate to severe knee osteoarthritis, with no serious adverse events reported. The investor webinar is scheduled for March 5, 2025, at 11:00 a.m. ET, featuring CEO Oren Hershkovitz Ph.D., who will provide detailed insights into these promising interim results.

Positive

• 47% reduction in pain with statistical significance (P=0.0001)
• 46% improvement in joint function
• 83% response rate maintained at 6 months
• No serious adverse events reported
• Strong durability of treatment effect shown

Negative

• Only Phase I interim data available
• Full trial results still pending

Insights

Clinical Research Expert

Enlivex's interim data from their Phase I/II Allocetra™ trial represents a potentially significant advancement in osteoarthritis treatment. The 47.0% pain reduction (P=0.0001) substantially exceeds the 30% threshold typically considered clinically meaningful. Similarly, the 46% functional improvement and 83% six-month responder rate suggest both potency and durability uncommon in current osteoarthritis interventions.

The clean safety profile is particularly encouraging for an immunomodulatory approach. Osteoarthritis has traditionally been viewed as a mechanical wear-and-tear condition, but increasing evidence points to inflammatory components where macrophage reprogramming could prove beneficial by addressing underlying disease biology rather than merely masking symptoms.

What sets these results apart is the sustained response at six months – most intra-articular injections show significant efficacy decline by 3-4 months. If this durability extends further, it could dramatically improve treatment paradigms for the millions suffering from knee osteoarthritis.

However, these findings represent early-stage data from the Phase I portion, typically involving a patient cohort. The statistical significance suggests robust effects, but confirmation in the larger Phase II component with proper controls will be important for validating these impressive initial signals.

Biotech Investment Analyst

Enlivex's positive interim data for Allocetra™ significantly strengthens their clinical pipeline and commercial prospects. The statistically significant efficacy demonstrated in knee osteoarthritis – a 47% pain reduction and 46% functional improvement – addresses an enormous market with effective interventions.

The osteoarthritis therapeutics market exceeds $7 billion annually with substantive growth projections due to aging demographics. Current treatments often provide inadequate relief or lose efficacy over time, creating substantial opportunity for novel, durable therapies like Allocetra™.

The 83% responder rate at six months post-treatment is particularly compelling, suggesting potential for significant market penetration if later-stage trials confirm these results. For perspective, many current therapies show responder rates below 50% at comparable timepoints.

For a clinical-stage company with ~$22.4M market cap, this positive data could represent an inflection point. The clean safety profile reduces developmental risk, while the efficacy signals provide potential validation for Enlivex's broader macrophage reprogramming platform beyond this single indication.

Investors should note that despite these encouraging results, Allocetra™ still faces the standard risks of clinical development, including the need for successful completion of the Phase II portion and subsequent pivotal trials before potential commercialization.

Ness-Ziona, Israel, March 04, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, is pleased to invite investors to a live investor webinar on March 5, 2025, at 11:00 a.m. ET to discuss the positive interim six-month data from the Phase I stage of its ongoing randomized, multi-country Phase I/II Allocetra™ trial in patients with moderate to severe knee osteoarthritis.

The exclusive event, hosted by RedChip Companies, will feature the Company’s Chief Executive Officer, Oren Hershkovitz Ph.D., who will provide a detailed review of the interim results, which demonstrated a statistically significant 47.0% average reduction in reported pain (P=0.0001) and a 46% improvement in joint function at six months post-treatment. Additionally, 83% of treated patients were still considered responders to treatment at six months, which the Company believes highlights the durability and sustained efficacy of Allocetra™ as a potential breakthrough treatment for osteoarthritis. Importantly, no serious adverse events were reported, reinforcing the favorable safety profile of Allocetra™.

Dr. Hershkovitz commented, “We are excited by these promising interim results, which showcase Allocetra™’s potential to deliver meaningful and sustained, pain relief for patients suffering from moderate to severe knee osteoarthritis. The consistency and durability of the efficacy data—combined with the safety profile—underscore Allocetra™’s promising potential to become a novel treatment in a space with urgent unmet medical needs. We remain deeply committed to advancing this innovative therapy and unlocking its full potential for millions of patients worldwide.”

Webinar Details

• Date: March 5, 2025
• Time: 11:00 a.m. ET

To register for the free webinar, please visit: https://redchip.zoom.us/webinar/register/WN_ZHfRf-8_R3etRq2e5iIPUg

A live Q&A session will follow the presentation. Questions can be pre-submitted to ENLV@redchip.com or online during the live event.

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 http://www.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, 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.

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

FAQ

What are the key efficacy results from Enlivex's (ENLV) Phase I/II Allocetra trial in knee osteoarthritis?

The trial showed 47% pain reduction (P=0.0001), 46% joint function improvement, and 83% of patients maintaining response at 6 months post-treatment.

How safe is Allocetra based on ENLV's Phase I/II knee osteoarthritis trial data?

The interim data showed no serious adverse events, demonstrating a favorable safety profile for Allocetra.

What is the duration of Allocetra's treatment effect in ENLV's knee osteoarthritis trial?

The treatment showed sustained efficacy with 83% of patients still responding at 6 months post-treatment.

When will ENLV present detailed results from the Allocetra knee osteoarthritis trial?

ENLV will present detailed interim results in an investor webinar on March 5, 2025, at 11:00 a.m. ET.

What stage is ENLV's Allocetra trial for knee osteoarthritis currently in?

The trial is currently in a Phase I/II stage, with these results representing interim data from the Phase I portion.