Enlivex Receives Authorization from the Danish Medicines Agency to Initiate the Phase II Stage of its Phase I/II Trial of Allocetra in Patients with Moderate to Severe Knee Osteoarthritis
Enlivex Therapeutics (Nasdaq: ENLV) has received authorization from the Danish Medicines Agency to initiate the Phase II stage of its Phase I/II trial for Allocetra™ in patients with moderate to severe knee osteoarthritis. This approval follows a recommendation by the independent Data and Safety Monitoring Board (DSMB) to proceed to Phase II. The trial consists of two stages: a Phase I safety run-in, open-label dose escalation phase, and a Phase II double-blind, randomized, placebo-controlled stage.
The Phase II stage will evaluate both safety and efficacy of Allocetra™ injections into the knee, with primary measurements assessing joint-pain and joint-function compared to placebo at three, six, and 12 months post-treatment. Dr. Einat Galamidi, Medical Vice President of Enlivex, expressed satisfaction with Allocetra™'s safety profile following three sequential intra-articular knee injections in the first twelve patients of the Phase I stage.
Enlivex Therapeutics (Nasdaq: ENLV) ha ricevuto l'autorizzazione dall'Agenzia danese dei medicinali per avviare la fase II del suo trial di fase I/II per Allocetra™ in pazienti con osteoartrite del ginocchio da moderata a grave. Questa approvazione segue una raccomandazione del Consiglio indipendente per il monitoraggio dei dati e della sicurezza (DSMB) per procedere alla fase II. Il trial consiste di due fasi: una fase di sicurezza di fase I, aperta e di escalation del dosaggio, e una fase II randomizzata, in doppio cieco e controllata con placebo.
La fase II valuterà sia la sicurezza che l'efficacia delle iniezioni di Allocetra™ nel ginocchio, con misurazioni primarie che valutano il dolore articolare e la funzionalità articolare rispetto al placebo a tre, sei e dodici mesi dopo il trattamento. La Dr.ssa Einat Galamidi, Vicepresidente Medico di Enlivex, ha espresso soddisfazione per il profilo di sicurezza di Allocetra™ dopo tre iniezioni intra-articolari consecutive nel ginocchio nei primi dodici pazienti della fase I.
Enlivex Therapeutics (Nasdaq: ENLV) ha recibido autorización de la Agencia Danesa de Medicamentos para iniciar la fase II de su ensayo de fase I/II para Allocetra™ en pacientes con osteoartritis de rodilla de moderada a severa. Esta aprobación sigue a una recomendación de la Junta de Monitoreo de Datos y Seguridad (DSMB) para avanzar a la fase II. El ensayo consta de dos etapas: una fase de seguridad de fase I, abierta y de escalada de dosis, y una fase II aleatorizada, doble ciego y controlada con placebo.
La fase II evaluará tanto la seguridad como la eficacia de las inyecciones de Allocetra™ en la rodilla, con medidas primarias que evaluarán el dolor articular y la función articular en comparación con el placebo a los tres, seis y doce meses después del tratamiento. La Dra. Einat Galamidi, Vicepresidenta Médica de Enlivex, expresó su satisfacción con el perfil de seguridad de Allocetra™ tras tres inyecciones intraarticulares consecutivas en la rodilla de los primeros doce pacientes de la fase I.
Enlivex Therapeutics (Nasdaq: ENLV)는 중증의 무릎 골관절염 환자를 위한 Allocetra™의 1/2상 임상시험의 2상 단계를 시작할 수 있도록 덴마크 의약품청의 승인을 받았습니다. 이 승인은 독립 데이터 및 안전성 모니터링 위원회(DSMB)의 권고에 따라 2상으로 진행하기 위해 이루어졌습니다. 이 시험은 두 단계로 구성되어 있으며, 1상 안전성 시험, 오픈 레이블 및 용량 상승 단계와 2상 이중 맹검, 무작위, 위약 대조 단계가 포함됩니다.
2상 단계는 Allocetra™ 주사의 안전성과 효능을 평가할 것이며, 1차 측정은 치료 후 3, 6, 12개월째 위약과 비교하여 관절 통증 및 관절 기능을 평가합니다. Enlivex의 의학 부사장인 Einat Galamidi 박사는 1상 단계의 첫 번째 12명 환자에게 시행된 3회의 연속 관절 내 무릎 주사 후 Allocetra™의 안전성 프로필에 대한 만족감을 표명했습니다.
Enlivex Therapeutics (Nasdaq: ENLV) a reçu l'autorisation de l'Agence danoise des médicaments pour commencer la phase II de son essai de phase I/II pour Allocetra™ chez des patients atteints d'arthrose du genou modérée à sévère. Cette approbation fait suite à une recommandation du Comité de surveillance des données et de la sécurité (DSMB) pour procéder à la phase II. L'essai se compose de deux phases : une phase I de sécurité, ouverte et d'escalade de dosage, et une phase II randomisée, en double aveugle et contrôlée par placebo.
La phase II évaluera à la fois la sécurité et l'efficacité des injections d'Allocetra™ dans le genou, avec des mesures principales évaluant la douleur articulaire et la fonction articulaire par rapport au placebo à trois, six et douze mois après le traitement. Dr. Einat Galamidi, Vice-présidente médicale d’Enlivex, a exprimé sa satisfaction quant au profil de sécurité d’Allocetra™ après trois injections intra-articulaires consécutives dans le genou chez les douze premiers patients de la phase I.
Enlivex Therapeutics (Nasdaq: ENLV) hat die Genehmigung der dänischen Arzneimittelbehörde erhalten, die Phase II seiner Phase I/II-Studie für Allocetra™ bei Patienten mit mäßiger bis schwerer Kniearthrose einzuleiten. Diese Genehmigung folgt einer Empfehlung des unabhängigen Daten- und Sicherheitsüberwachungsausschusses (DSMB) zur Fortsetzung in Phase II. Die Studie besteht aus zwei Phasen: einer Phase I Sicherheitsstudie, einer offenen Dosiserhöhungsphase und einer Phase II, die doppelblind, randomisiert und placebo-kontrolliert ist.
Die Phase II wird sowohl die Sicherheit als auch die Wirksamkeit der Allocetra™-Injektionen ins Knie bewerten, wobei die primären Messungen die Gelenkschmerzen und die Gelenkfunktionen im Vergleich zum Placebo nach drei, sechs und zwölf Monaten nach der Behandlung bewerten. Dr. Einat Galamidi, Medizinische Vizepräsidentin von Enlivex, äußerte Zufriedenheit mit dem Sicherheitsprofil von Allocetra™ nach drei aufeinanderfolgen intraartikulären Knieinjektionen bei den ersten zwölf Patienten der Phase I.
- Authorization received to initiate Phase II stage of Allocetra™ trial for knee osteoarthritis
- Positive safety profile demonstrated in Phase I stage with 12 patients
- Trial designed to assess both safety and efficacy of Allocetra™ injections
- None.
Insights
The Danish Medicines Agency's authorization for Enlivex to initiate the Phase II stage of its Allocetra trial in knee osteoarthritis is a significant milestone. This progression, following the DSMB's recommendation, indicates a positive safety profile for Allocetra in the Phase I stage. The trial's design, moving from an open-label dose escalation to a double-blind, randomized, placebo-controlled study, is robust and well-structured.
The focus on moderate to severe knee osteoarthritis targets a substantial market, given the prevalence of this condition. The primary endpoints of joint pain and function at 3, 6 and 12 months post-treatment are clinically relevant and could demonstrate both short and long-term efficacy. If successful, Allocetra could potentially offer a novel treatment option in a field where current therapies often have efficacy or significant side effects.
However, investors should note that Phase II trials still carry significant risks and success is not guaranteed. The timeline for potential commercialization remains distant and further funding may be required to complete clinical development.
Nes-Ziona, Israel, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Danish Medicines Agency authorized the initiation of the Phase II stage of the Company’s multi-country Phase I/II trial in moderate and severe knee osteoarthritis. This approval follows the recently announced recommendation by the independent Data and Safety Monitoring Board (DSMB) that the Company may move forward to the Phase II stage of the trial.
The Phase I/II multi-center clinical trial is composed of two stages. The first stage is a Phase I 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 subsequent Phase II stage. The Phase II stage is a double-blind, randomized, placebo-controlled stage, which the Company is now initiating following the completion of the safety run-in stage and the safety confirmation by the DSMB, which the Company recently announced. In addition to evaluating safety, the blinded randomized stage is statistically-powered to assess the efficacy of Allocetra™ injections into the knee. The Company expects that the primary measurements will evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months after treatment.
Einat Galamidi, MD, Medical Vice President of Enlivex, commented, “We are pleased with the safety profile of Allocetra™ following three sequential intra-articular knee injections, as demonstrated in the first twelve patients in the Phase I safety run-in stage of this trial, and the approval to progress into the double-blind, randomized, placebo controlled Phase II stage.”
ABOUT KNEE OSTEOARTHRITIS1
Osteoarthritis is by far the most common form of arthritis, affecting more than 32.5 million Americans and more than 300 million individuals worldwide. About half of knees with ACL injuries develop osteoarthritis within 5 to 15 years. 78 million Americans are projected to have osteoarthritis by the year 2040. Symptomatic knee osteoarthritis is particularly prevalent and disabling, with
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,” “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, 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
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1 Source: The Arthritis Foundation; Disease modification in osteoarthritis; pathways to drug approval, Katz et. Al., Osteoarthritis and Cartilage Open (2) (2020)
FAQ
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