Enlivex Announces the Dosing of the First Patient in a Phase I Trial Evaluating Allocetra in Patients with TMJ Osteoarthritis
Enlivex Therapeutics (Nasdaq: ENLV) has initiated dosing in a Phase I trial evaluating Allocetra™ for temporomandibular joint (TMJ) osteoarthritis patients. The investigator-initiated study, conducted at Sheba Medical Center, aims to assess the safety, tolerability, and initial efficacy of Allocetra™ when injected into the TMJ.
The trial will enroll six patients who have not responded adequately to conventional TMJ osteoarthritis treatments. The study's primary safety endpoint will evaluate adverse events frequency and severity, while efficacy endpoints will measure changes in TMJ pain, joint functionality, and other disease parameters over a 12-month follow-up period.
TMJ osteoarthritis, affecting 5-12% of the global population, is a degenerative and progressive condition causing jaw pain and stiffness, with currently no effective long-term treatments available.
Enlivex Therapeutics (Nasdaq: ENLV) ha avviato la somministrazione in uno studio di Fase I che valuta Allocetra™ per pazienti con osteoartrite dell'articolazione temporomandibolare (ATM). Lo studio, avviato dagli investigatori e condotto presso il Sheba Medical Center, mira a valutare la sicurezza, la tollerabilità e l'efficacia iniziale di Allocetra™ quando iniettato nell'ATM.
Lo studio arruolerà sei pazienti che non hanno risposto adeguatamente ai trattamenti convenzionali per l'osteoartrite dell'ATM. L'obiettivo primario di sicurezza dello studio valuterà la frequenza e la gravità degli eventi avversi, mentre gli obiettivi di efficacia misureranno i cambiamenti nel dolore dell'ATM, nella funzionalità articolare e in altri parametri della malattia durante un periodo di follow-up di 12 mesi.
L'osteoartrite dell'ATM, che colpisce il 5-12% della popolazione globale, è una condizione degenerativa e progressiva che causa dolore e rigidità alla mandibola, con attualmente nessun trattamento efficace a lungo termine disponibile.
Enlivex Therapeutics (Nasdaq: ENLV) ha iniciado la administración en un ensayo de Fase I que evalúa Allocetra™ para pacientes con osteoartritis de la articulación temporomandibular (ATM). El estudio, iniciado por investigadores y llevado a cabo en el Sheba Medical Center, tiene como objetivo evaluar la seguridad, la tolerabilidad y la eficacia inicial de Allocetra™ cuando se inyecta en la ATM.
El ensayo inscribirá a seis pacientes que no han respondido adecuadamente a los tratamientos convencionales para la osteoartritis de la ATM. El objetivo primario de seguridad del estudio evaluará la frecuencia y gravedad de los eventos adversos, mientras que los objetivos de eficacia medirán los cambios en el dolor de la ATM, la funcionalidad articular y otros parámetros de la enfermedad durante un período de seguimiento de 12 meses.
La osteoartritis de la ATM, que afecta al 5-12% de la población mundial, es una condición degenerativa y progresiva que causa dolor y rigidez en la mandíbula, sin tratamientos efectivos a largo plazo disponibles en la actualidad.
Enlivex Therapeutics (Nasdaq: ENLV)는 Allocetra™의 턱관절(TMJ) 골관절염 환자를 위한 1상 시험에서 투약을 시작했습니다. 연구자 주도 연구는 Sheba Medical Center에서 진행되며, TMJ에 주사했을 때 Allocetra™의 안전성, 내약성 및 초기 효능을 평가하는 것을 목표로 합니다.
이 시험에는 기존 TMJ 골관절염 치료에 충분히 반응하지 않은 6명의 환자가 등록될 예정입니다. 연구의 주요 안전성 목표는 부작용의 빈도와 심각성을 평가하고, 효능 목표는 12개월 추적 관찰 기간 동안 TMJ 통증, 관절 기능 및 기타 질병 매개변수의 변화를 측정합니다.
TMJ 골관절염은 전 세계 인구의 5-12%에 영향을 미치는 퇴행성 및 진행성 질환으로, 턱의 통증과 경직을 유발하며 현재 장기적으로 효과적인 치료법이 없습니다.
Enlivex Therapeutics (Nasdaq: ENLV) a lancé la dose dans un essai de Phase I évaluant Allocetra™ pour les patients atteints d'arthrose de l'articulation temporomandibulaire (ATM). L'étude, initiée par des chercheurs et réalisée au Sheba Medical Center, vise à évaluer la sécurité, la tolérance et l'efficacité initiale d'Allocetra™ lorsqu'il est injecté dans l'ATM.
L'essai recrutera six patients qui n'ont pas répondu de manière adéquate aux traitements conventionnels de l'arthrose de l'ATM. Le critère principal de sécurité de l'étude évaluera la fréquence et la gravité des événements indésirables, tandis que les critères d'efficacité mesureront les changements dans la douleur de l'ATM, la fonctionnalité articulaire et d'autres paramètres de la maladie sur une période de suivi de 12 mois.
L'arthrose de l'ATM, qui touche 5-12 % de la population mondiale, est une affection dégénérative et progressive causant des douleurs et une raideur de la mâchoire, sans traitements efficaces à long terme disponibles actuellement.
Enlivex Therapeutics (Nasdaq: ENLV) hat die Dosierung in einer Phase-I-Studie begonnen, die Allocetra™ bei Patienten mit Osteoarthritis des Kiefergelenks (TMJ) bewertet. Die vom Prüfer initiierte Studie, die im Sheba Medical Center durchgeführt wird, zielt darauf ab, die Sicherheit, Verträglichkeit und anfängliche Wirksamkeit von Allocetra™ bei Injektion in das TMJ zu bewerten.
Die Studie wird sechs Patienten einschließen, die nicht ausreichend auf herkömmliche Behandlungen der TMJ-Osteoarthritis reagiert haben. Der primäre Sicherheitsendpunkt der Studie wird die Häufigkeit und Schwere von unerwünschten Ereignissen bewerten, während die Wirksamkeitsendpunkte Veränderungen bei TMJ-Schmerzen, Gelenkfunktionalität und anderen Krankheitsparametern über einen Zeitraum von 12 Monaten messen werden.
Die TMJ-Osteoarthritis, die 5-12% der Weltbevölkerung betrifft, ist eine degenerative und fortschreitende Erkrankung, die Kieferschmerzen und Steifheit verursacht, wobei derzeit keine effektiven langfristigen Behandlungen verfügbar sind.
- First patient successfully dosed with no complications
- Trial conducted at prestigious Sheba Medical Center, ranked among top 10 hospitals globally
- Addresses unmet medical need with no current effective long-term treatments
- Targets condition affecting 5-12% of global population
- Early-stage Phase I trial with patient enrollment (only 6 patients)
- to patients who failed conventional therapies, which may affect results
- Extended 12-month follow-up period could delay results and potential commercialization
Insights
The dosing of the first patient in Enlivex's Phase I TMJ osteoarthritis trial represents an early but meaningful clinical milestone for the company's macrophage reprogramming platform. This investigator-initiated study at Sheba Medical Center (a top 10 global hospital) is significant for several reasons:
TMJ osteoarthritis affects
From a development perspective, this study will evaluate both safety and preliminary efficacy in six patients who have failed conventional therapies, with an extended 12-month follow-up period. The successful administration of the first injection without complications is an encouraging initial safety signal.
However, investors should contextually understand this is a very early-stage clinical program with a small patient population. As a Phase I trial, it's primarily designed to evaluate safety rather than definitive efficacy. The investigator-initiated structure suggests Enlivex is exploring this indication without substantial resource commitment, which is strategically sound for a company with
While this represents potential expansion of Allocetra's applications beyond Enlivex's core development programs, any commercial implications remain years away and would require successful completion of this study followed by larger trials.
- Temporomandibular joint (TMJ) osteoarthritis is a degenerative, debilitating and progressive disease, the second most common musculoskeletal condition affecting five to
12% of the population globally - TMJ causes pain and stiffness in the jaw, making it difficult to chew
- TMJ osteoarthritis currently has no long-term effective treatments
Ness-Ziona, Israel, April 03, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company” or “Enlivex”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed in an investigator-initiated Phase I trial to evaluate the safety, tolerability and initial efficacy of Allocetra™ for injection into the temporomandibular joint (TMJ) in patients suffering from TMJ osteoarthritis.
The study will be conducted by the Rheumatology Unit at Sheba Medical Center in collaboration with the Department of Oral and Maxillofacial Surgery at Sheba Medical Center. Notably, Sheba Medical Center was recently ranked among the top 10 hospitals in the world by Newsweek.
Dr. Einat Galamidi, CMO of Enlivex, commented, “This study will provide a preliminary evaluation of the safety and potential effect of AllocetraTM for the treatment of TMJ osteoarthritis, which affects a joint that is critical for daily function. We are pleased to report that the injection of AllocteraTM into the first patient’s TMJ was successfully completed with no complications.”
The trial currently plans to recruit six patients who have insufficiently responded to conventional therapies for TMJ osteoarthritis. The trial’s primary safety endpoint will measure the frequency and severity of adverse events and serious adverse events, and efficacy endpoints will assess changes from baseline in TMJ pain, joint functionality, and other disease parameters for up to 12 months following administration of Allocetra™.
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 TEMPOROMANDIBULAR JOINT (TMJ) OSTEOARTHRITIS
TMJ disorders are the second most common musculoskeletal condition affecting five to
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, expected clinical trial results, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRATM 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 ALLOCETRATM 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 Bianchi et al., Sci Rep 2020
2 Delpachitra et al., British Journal of Oral and Maxillofacial Surgery 60 (2022)
FAQ
What is the primary objective of ENLV's Phase I trial for TMJ osteoarthritis?
How many patients will be enrolled in ENLV's TMJ osteoarthritis trial?
What is the follow-up period for ENLV's TMJ osteoarthritis trial?
What are the key endpoints in ENLV's Phase I TMJ trial?
