Enlivex to Present 3-Month Topline Data from Phase IIa Moderate/Severe Knee Osteoarthritis Trial on August 18 Webinar
Enlivex Therapeutics (Nasdaq: ENLV) announced a webinar scheduled for August 18, 2025, at 8:00 AM ET to present 3-month topline results from its Phase IIa trial of Allocetra™ for moderate to severe knee osteoarthritis. The study, ENX-CL-05-001, is a double-blind, randomized, placebo-controlled multi-center trial.
The trial has enrolled 134 patients who have completed the 3-month follow-up period. The Phase IIa stage follows a completed Phase I open-label dose-escalation study that evaluated safety, tolerability, and optimal dosing. The trial addresses knee osteoarthritis, which affects over 32.5 million Americans and 300 million people worldwide, with 40% of men and 47% of women developing it in their lifetimes.
Enlivex Therapeutics (Nasdaq: ENLV) ha annunciato un webinar in programma per 18 agosto 2025 alle 8:00 ET per presentare i risultati principali a 3 mesi del suo studio di Fase IIa su Allocetra™ per l'osteoartrosi del ginocchio da moderata a grave. Lo studio, ENX-CL-05-001, è uno studio multicentrico, randomizzato, in doppio cieco e controllato con placebo.
Lo studio ha arruolato 134 pazienti che hanno completato il periodo di follow-up a 3 mesi. La Fase IIa segue una Fase I completata, in aperto con escalation di dose, che ha valutato sicurezza, tollerabilità e il dosaggio ottimale. Lo studio riguarda l'osteoartrosi del ginocchio, che colpisce oltre 32,5 milioni di americani e 300 milioni di persone nel mondo, con il 40% degli uomini e il 47% delle donne che la svilupperanno nel corso della vita.
Enlivex Therapeutics (Nasdaq: ENLV) anunció un webinar programado para el 18 de agosto de 2025 a las 8:00 AM ET para presentar los resultados principales a 3 meses de su ensayo de Fase IIa de Allocetra™ para la artrosis de rodilla de moderada a grave. El estudio, ENX-CL-05-001, es un ensayo multicéntrico, aleatorizado, doble ciego y controlado con placebo.
El ensayo ha inscrito a 134 pacientes que han completado el periodo de seguimiento de 3 meses. La Fase IIa sigue a una Fase I abierta de escalada de dosis ya completada, que evaluó la seguridad, la tolerabilidad y la dosificación óptima. La investigación aborda la artrosis de rodilla, que afecta a más de 32,5 millones de estadounidenses y a 300 millones de personas en todo el mundo, con un 40% de hombres y un 47% de mujeres que la desarrollarán a lo largo de su vida.
Enlivex Therapeutics (Nasdaq: ENLV)는 2025년 8월 18일 오전 8:00(동부시간)에 중등도에서 중증 무릎 골관절염을 대상으로 한 Allocetra™의 임상 2a상 3개월 주요 결과를 발표하는 웨비나를 개최한다고 발표했습니다. 연구 ENX-CL-05-001은 다기관, 무작위배정, 이중맹검, 위약대조 연구입니다.
이 임상시험에는 134명의 환자가 등록되어 3개월 추적 관찰을 완료했습니다. 2a상은 안전성, 내약성 및 최적 용량을 평가한 공개 라벨(오픈라벨) 용량 증가 1상을 마친 후에 진행된 단계입니다. 무릎 골관절염은 미국에서 3,250만 명 이상, 전 세계적으로 3억 명 이상이 앓고 있으며 남성의 40%와 여성의 47%가 평생 동안 발병합니다.
Enlivex Therapeutics (Nasdaq: ENLV) a annoncé un webinaire prévu le 18 août 2025 à 8h00 (heure de l'Est) pour présenter les résultats principaux à 3 mois de son essai de phase IIa d'Allocetra™ pour l'arthrose du genou modérée à sévère. L'étude ENX-CL-05-001 est un essai multicentrique, randomisé, en double aveugle et contrôlé par placebo.
L'essai a recruté 134 patients ayant terminé la période de suivi de 3 mois. La phase IIa fait suite à une phase I ouverte d'escalade de dose achevée, qui a évalué la sécurité, la tolérabilité et la posologie optimale. L'essai concerne l'arthrose du genou, qui touche plus de 32,5 millions d'Américains et 300 millions de personnes dans le monde, 40 % des hommes et 47 % des femmes en étant affectés au cours de leur vie.
Enlivex Therapeutics (Nasdaq: ENLV) gab ein Webinar für den 18. August 2025 um 8:00 Uhr ET bekannt, in dem die 3‑Monats‑Topline‑Ergebnisse seiner Phase‑IIa‑Studie zu Allocetra™ bei mäßiger bis schwerer Kniearthrose vorgestellt werden. Die Studie ENX-CL-05-001 ist eine multizentrische, randomisierte, doppelblinde, placebokontrollierte Studie.
Die Studie hat 134 Patienten eingeschlossen, die die 3‑monatige Nachbeobachtung abgeschlossen haben. Die Phase IIa folgt auf eine abgeschlossene, offene Phase‑I‑Dosissteigerungsstudie, die Sicherheit, Verträglichkeit und die optimale Dosierung untersucht hat. Die Studie befasst sich mit Kniearthrose, die über 32,5 Millionen Amerikaner und 300 Millionen Menschen weltweit betrifft; 40 % der Männer und 47 % der Frauen entwickeln sie im Laufe ihres Lebens.
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Webinar to Review Results from Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Allocetra™ in Patients with Moderate to Severe Knee Osteoarthritis
Nes-Ziona, Israel, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced it will host a webinar on Monday, August 18, 2025, at 8:00 AM Eastern Time to present and discuss 3-month topline results from the Phase IIa stage of its Phase I/IIa ENX-CL-05-001 trial, a double-blind, randomized, placebo-controlled multi-centered study.
The webinar will feature a detailed analysis of 3-month topline data from the Phase IIa stage of ENX-CL-05-001, a multi-center, two-stage Phase I/II trial evaluating Allocetra™ in patients with moderate-to-severe knee osteoarthritis.
Register now to reserve your spot for the webinar: https://www.redchip.com/webinar/ENLV/87053863717
Osteoarthritis, the most common form of arthritis, affects more than 32.5 million Americans and more than 300 million people worldwide; symptomatic knee osteoarthritis is especially prevalent and disabling, with
The ongoing Phase IIa stage is a double-blind, randomized, placebo-controlled trial, assessing both safety and efficacy, with endpoints measuring joint pain and function versus placebo at 3, 6, and 12 months post-injection. An interim analysis, conducted by an independent third party, was designed to evaluate the potential benefits of expanding enrollment from 130 to 180 patients and to identify possible responder sub-populations. To date, 134 patients have completed the 3-month follow-up period, the trial’s primary timepoint for measuring key endpoints.
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, 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
FAQ
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