Enlivex Receives IMOH Regulatory Authorization for the Initiation of a Multi-Country, Randomized, Controlled Phase I/II Trial Evaluating Allocetra in Up To 160 Patients with Moderate to Severe Knee Osteoarthritis
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced the authorization from the Israeli Ministry of Health for a multi-country Phase I/II trial to evaluate the efficacy, safety, and tolerability of Allocetra™ injections into the target knee joint of up to 160 moderately to severely symptomatic osteoarthritis patients. The trial will consist of a safety run-in, open-label dose escalation phase, followed by a double-blind, randomized, placebo-controlled stage. The primary measurements will assess joint-pain and joint-function compared to placebo at three months, six months, and 12 months.
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Authorization from the Israeli Ministry of Health for a multi-country Phase I/II trial
Focus on inflammatory diseases and specifically pushing forward the osteoarthritis development program
The authorization of a Phase I/II clinical trial for Allocetra™ by the Israeli Ministry of Health marks a significant step in the development of treatments for osteoarthritis, a condition affecting millions worldwide. The focus on macrophage reprogramming is indicative of a shift towards more targeted immunotherapies in treating chronic inflammatory conditions. From a research standpoint, the design of the trial—double-blind, randomized and placebo-controlled—meets the gold standard for determining the efficacy and safety of new treatments. The inclusion of a safety run-in phase is a prudent measure to ensure patient safety before proceeding to the larger randomized stage.
The trial's primary endpoints, which include joint-pain and joint-function assessments at multiple intervals, are appropriate measures of clinical relevance. Efficacy at these time points could suggest both immediate and sustained benefits from the therapy. However, it is crucial to note that the trial is early stage and positive outcomes are not guaranteed. The biotech sector is known for its volatility and the success of clinical trials can have a substantial impact on a company's valuation. An effective treatment for osteoarthritis would address a significant unmet medical need, potentially leading to a sizable market opportunity for Enlivex.
Enlivex Therapeutics' initiation of a Phase I/II trial for Allocetra™ in knee osteoarthritis has implications for the company's financial outlook. The progression of this trial represents a key operational milestone with the potential to unlock value for shareholders if the results are positive. Investors will be closely monitoring the trial's progress, as clinical success could lead to increased investor confidence and potentially higher stock valuations.
It is important for investors to consider the costs associated with multi-country clinical trials, which can be substantial. However, successful trials can lead to partnerships, licensing deals, or even acquisition interest from larger pharmaceutical companies. It is also worth noting that the osteoarthritis market is highly competitive and the entry of a new, effective treatment could disrupt existing market dynamics. Long-term benefits for Enlivex hinge on the ability to navigate regulatory pathways, secure marketing approvals and establish commercialization strategies.
Osteoarthritis is a prevalent condition with a growing patient population due to aging demographics and increasing obesity rates. The current treatment landscape is dominated by pain management and symptomatic relief, often with nonsteroidal anti-inflammatory drugs (NSAIDs) and intra-articular injections. A novel therapy like Allocetra™, which targets macrophage reprogramming, could differentiate itself in the market. The potential for Allocetra™ to provide a new mechanism of action addresses a gap in the treatment paradigm, particularly for moderate to severe cases where options are limited.
Market adoption of new therapies depends on factors such as efficacy, safety, cost and ease of administration. The trial's outcome will have a direct bearing on these aspects. If Allocetra™ proves to be effective and safe, it could capture a significant share of the osteoarthritis treatment market, which is expected to grow in the coming years. The economic burden of osteoarthritis is substantial, with direct and indirect costs from lost work productivity and healthcare expenses. A therapy that can improve joint function and reduce pain without the side effects associated with current treatments could be well-received by both clinicians and patients.
01/17/2024 - 08:00 AM
Second study of Allocetra in knee osteoarthritis, following the on-going Phase I/II trial in pre-surgery, end-stage osteoarthritis, that is continuing to enroll patients Nes-Ziona, Israel, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Israeli Ministry of Health (IMOH) authorized the initiation of a Company-sponsored multi-country, double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the efficacy, safety and tolerability of Allocetra™ following injections into the target knee joint of up to 160 moderately to severely symptomatic osteoarthritis patients.
The Phase I/II multi-center trial 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 Allocetra™ injections to the target knee in order to identify the dose and injection regimen 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 confirmation by the safety and tolerability independent Data Safety Monitoring Board. On top of evaluating safety, the blinded randomized stage is statistically-powered to assess the efficacy of Allocetra™ injections into the knee. The primary measurements will be comparisons of joint-pain and joint-function compared to placebo at three months, six months and 12 months.
“Following the enrollment progress of knee osteoarthritis end-stage patients in a Phase I/II investigator-initiated clinical trial, we are now expanding the osteoarthritis vertical to include moderate and severe osteoarthritis patients, who comprise the majority segment of the knee osteoarthritis population” said Einat Galamidi, M.D., Vice President, Medical of Enlivex. “Macrophages are now considered as an emerging therapeutic target in the treatment of osteoarthritis, and the macrophage reprograming mechanism of action of Allocetra™ positions it as a potentially promising therapy for this substantial unmet life-debilitating indication.”
Oren Hershkovitz, Ph.D., CEO of Enlivex said, “As announced in September 2023, we are increasing our focus on inflammatory diseases and specifically pushing forward the osteoarthritis development program. The IMOH approval is an important operational milestone enabling us to continue the evaluation of Allocetra™ safety and efficacy in knee osteoarthritis patients in a statistically-powered, blinded, randomized controlled study.”
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 clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.
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™ 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™ 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 CONTACTshachar@enlivexpharm.com
The purpose is to evaluate the efficacy, safety, and tolerability of Allocetra™ injections into the target knee joint of up to 160 moderately to severely symptomatic osteoarthritis patients.
The primary measurements will be comparisons of joint-pain and joint-function compared to placebo at three months, six months, and 12 months.
Einat Galamidi, M.D. is the Vice President, Medical of Enlivex.
Oren Hershkovitz, Ph.D. is the CEO of Enlivex.
