Enlivex Announces the Dosing of the First Patient in a Randomized, Placebo-Controlled Phase I/II Trial Evaluating AllocetraTM in up to 46 Patients with Thumb Osteoarthritis

Rhea-AI Summary

Enlivex Therapeutics announced the dosing of the first patient in a Phase I/II clinical trial evaluating AllocetraTM for thumb osteoarthritis. This condition, affecting millions, currently has no FDA-approved therapies. The trial, involving up to 46 patients, is divided into two stages: an open-label dose escalation phase to assess safety and tolerability, followed by a randomized, placebo-controlled stage. The primary endpoint is the frequency and severity of adverse events, while efficacy will be measured through changes in pain and function over 12 months. CEO Oren Hershkovitz highlighted the swift enrollment and successful dosing of the first patient.

Positive

• First patient dosed in the trial, advancing clinical development.
• Swift enrollment of the first patient, indicating strong interest and efficient processes.
• Successful initial dosing with no complications reported.

Negative

• No FDA-approved therapies exist for thumb osteoarthritis, indicating a high unmet need and potential competition if approved.
• Trial is still in early stages, and results on safety and efficacy are pending.

Medical Research Analyst

The initiation of a Phase I/II trial for AllocetraTM represents a significant milestone for Enlivex, particularly in its application for thumb osteoarthritis, a condition lacking effective long-term treatments. This news is noteworthy because it marks a concrete step toward potentially filling a substantial unmet medical need. Phase I/II trials are early but important stages in clinical research, focusing on determining the safety and preliminary efficacy of new treatments. The safety run-in phase, followed by a randomized, placebo-controlled stage, is designed to rigorously evaluate both the safety and potential efficacy of AllocetraTM in reducing pain and improving function in patients.

From an investor's perspective, the successful commencement and swift enrollment indicate strong operational capabilities and scientific commitment. However, it is important to remain cautious as early-stage trials primarily assess safety and it will take time to gather substantial efficacy data. The primary safety endpoints, such as the frequency and severity of adverse events, will be pivotal. Should AllocetraTM demonstrate a favorable safety profile and meaningful efficacy, it could pave the way for subsequent larger trials and, potentially, regulatory approval.

Investors should watch for updates on the trial's progress, particularly the completion of the safety run-in stage and any interim results that might shed light on the treatment's impact on pain and function. While the news is promising, it is essential to keep in mind the inherent risks and uncertainties associated with early-stage clinical trials.

Market Research Analyst

Thumb osteoarthritis is a prevalent condition, affecting millions and lacking effective FDA-approved therapies. The market opportunity for a successful treatment in this domain is significant. Current therapies often fall short in providing long-term relief, creating a potential opening for AllocetraTM if proven effective. The targeted recruitment of up to 46 patients, with a robust design incorporating both safety and efficacy endpoints over a 12-month period, underscores the potential market impact of this trial.

For retail investors, the progression of this trial could signal future revenue streams and market positioning for Enlivex. An effective solution could command a high market share, given the current therapeutic void. Additionally, the trial's randomized, placebo-controlled nature enhances the rigor and credibility of the study, which is a positive indicator for future regulatory considerations and marketing strategies.

Nevertheless, investors should be aware of the timeline and the phased nature of clinical trials. Each phase is associated with specific risks and benchmarks and positive results in early trials are necessary but not sufficient for ultimate market success. Therefore, while the initiation of this trial is a positive development, it should be seen as an initial step in a long and uncertain journey.

 

• First patient dosed with Allocetra^TM in thumb osteoarthritis, a degenerative, debilitating and progressive disease that affects millions of people
• Thumb osteoarthritis currently has no FDA-approved therapy and no effective long-term treatments

Ness-Ziona, Israel, June 24, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed in an investigator-initiated, randomized, placebo-controlled Phase I/II trial evaluating the efficacy and safety of Allocetra™ following injection into patients with basal thumb joint (first carpometacarpal (CMC) joint) osteoarthritis, for which conventional therapies have failed.

This investigator-initiated Phase I/II trial plans to recruit up to 46 patients and is composed of two stages. The first stage is a safety run-in, open-label dose escalation phase to characterize the safety and tolerability of an Allocetra^TM injection in patients with osteoarthritis of the first basal thumb joint (first CMC joint) of the target thumb to identify the dose for the randomized stage. The second stage is a double-blind, randomized, placebo-controlled stage, which the Company expects to initiate following the completion of the safety run-in stage and selection of the safe and tolerable dose. Up to 40 patients will be randomized in a 1:1 ratio for treatment with either Allocetra^TM at the selected dose or placebo. The primary safety endpoint will measure the frequency and severity of adverse events and serious adverse events, and the efficacy endpoints will include assessments of change from baseline in pain and function for up to 12 months following treatment.

“This is the first injection of Alloctera^TM into the basal thumb joint, and we are pleased with the swift enrollment of the first patient just a few weeks following regulatory approval to initiate this trial. The injection of Alloctera^TM into the patient’s basal thumb joint was successfully completed with no complications.” stated Oren Hershkovitz, Ph.D., CEO of Enlivex.

ABOUT ALLOCETRA™

Allocetra™ is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra™ has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening and life-debilitating clinical indications that are defined as “unmet medical needs.”

ABOUT BASAL THUMB OSTEOARTHRITIS

Osteoarthritis of the thumb is a chronic condition causing pain, stiffness and occasional clicking and swelling in the joint at the base of thumb (also known as the carpometacarpal or CMC joint). Simple daily tasks can become painful and difficult. The prevalence of thumb osteoarthritis increases substantially with age and is more common in postmenopausal woman. The prevalence of radiographic base thumb OA was reported to be 5.8% and 7.3%, for 50-year-old males and females, respectively, while the respective prevalence for 80-year-old male and female participants was reported as 33.1% and 39.0%¹. The overall estimated symptomatic prevalence is up to 15% in adults over 30 years of age². Osteoarthritis of the thumb is a degenerative and progressive condition, and over time, conservative treatments and anti-inflammatory medication to reduce pain and swelling start losing their effectiveness. Currently, there are no effective long-term treatments for this disease. 

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 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.

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

1. Van Der Oest et al., 2021 - The prevalence of radiographic thumb base osteoarthritis: a meta-analysis.
2. Berger et al., 2015 - Management of osteoarthrosis of the thumb joints. 

 

FAQ

What is the latest update on Enlivex's AllocetraTM trial for thumb osteoarthritis?

Enlivex has dosed the first patient in the Phase I/II trial evaluating AllocetraTM for thumb osteoarthritis.

How many patients are involved in the AllocetraTM Phase I/II trial?

The trial plans to recruit up to 46 patients.

What are the primary and efficacy endpoints for the AllocetraTM trial?

The primary endpoint is the frequency and severity of adverse events, while efficacy is measured through changes in pain and function.

When was the first patient dosed in the AllocetraTM trial?

The first patient was dosed following regulatory approval in June 2024.

What is the design of the AllocetraTM Phase I/II trial?

The trial has an open-label dose escalation phase and a double-blind, randomized, placebo-controlled stage.