Enlivex Announces the Enrollment and Dosing of the First 10 Patient in the Randomized Phase II Stage of its Allocetra Trial in Patients with Moderate to Severe Knee Osteoarthritis
Enlivex Therapeutics (Nasdaq: ENLV) announced the enrollment and dosing of the first 10 patients in the randomized Phase II stage of its Allocetra™ trial for moderate to severe knee osteoarthritis. This follows the successful completion of Phase I safety run-in stage and approval from the Danish Medicines Agency. The Phase II stage is designed as a double-blind, randomized, placebo-controlled study, focusing on evaluating both safety and efficacy of Allocetra™ knee injections. The trial will assess joint-pain and joint-function compared to placebo at three, six, and 12 months post-treatment. Initial dosing showed no safety concerns.
Enlivex Therapeutics (Nasdaq: ENLV) ha annunciato l'arruolamento e la somministrazione dei primi 10 pazienti nella fase randomizzata Fase II del suo trial Allocetra™ per l'osteoartrite del ginocchio da moderata a grave. Questo segue il completamento con successo della fase di sicurezza Fase I e l'approvazione da parte dell'Agenzia Danese dei Medicinali. La Fase II è progettata come uno studio doppio cieco, randomizzato e controllato con placebo, focalizzandosi sulla valutazione sia della sicurezza che dell'efficacia delle iniezioni di Allocetra™ nel ginocchio. Il trial valuterà il dolore articolare e la funzionalità articolare rispetto al placebo a tre, sei e 12 mesi dopo il trattamento. La somministrazione iniziale non ha mostrato preoccupazioni riguardo alla sicurezza.
Enlivex Therapeutics (Nasdaq: ENLV) anunció la incorporación y dosificación de los primeros 10 pacientes en la Fase II del ensayo Allocetra™ para la osteoartritis del rodillo moderada a grave. Esto sigue al exitoso cumplimiento de la fase de seguridad de la Fase I y la aprobación por parte de la Agencia Danesa de Medicamentos. La Fase II está diseñada como un estudio doble ciego, aleatorizado y controlado con placebo, enfocado en evaluar tanto la seguridad como la eficacia de las inyecciones de Allocetra™ en la rodilla. El ensayo evaluará el dolor articular y la función articular en comparación con el placebo a tres, seis y 12 meses después del tratamiento. La dosificación inicial no mostró preocupaciones de seguridad.
Enlivex Therapeutics (Nasdaq: ENLV)는 중등도에서 중증의 무릎 골관절염을 위한 Allocetra™ 시험의 무작위 2상에 첫 10명의 환자 등록 및 투여를 발표했습니다. 이는 1상 안전성 시험의 성공적인 완료와 덴마크 의약품청의 승인에 따른 것입니다. 2상은 안전성과 효능을 평가하는 데 중점을 둔 이중 맹검 무작위 대조 시험으로 설계되었습니다. 이 시험은 치료 후 3개월, 6개월, 12개월 동안 플라시보와 비교하여 관절 통증 및 관절 기능을 평가합니다. 초기 투여는 안전성 문제를 보이지 않았습니다.
Enlivex Therapeutics (Nasdaq: ENLV) a annoncé l'enrôlement et la dose des dix premiers patients dans la phase II randomisée de son essai Allocetra™ pour l'arthrose du genou modérée à sévère. Cela fait suite à l'achèvement réussi de la phase I de sécurité et à l'approbation de l'Agence Danoise des Médicaments. La phase II est conçue comme une étude à double insu, randomisée et contrôlée par placebo, se concentrant sur l'évaluation tant de la sécurité que de l'efficacité des injections de genou Allocetra™. L'essai évaluera la douleur articulaire et la fonction articulaire par rapport au placebo à trois, six et douze mois après le traitement. La première dose n'a montré aucune préoccupation en matière de sécurité.
Enlivex Therapeutics (Nasdaq: ENLV) hat die Rekrutierung und Dosierung der ersten 10 Patienten in der randomisierten Phase II seiner Allocetra™-Studie zur moderaten bis schweren Knie-Osteoarthritis bekannt gegeben. Dies folgt auf den erfolgreichen Abschluss der Phase I Sicherheitsstudie und die Genehmigung der Dänischen Arzneimittelbehörde. Die Phase II ist als doppelblindes, randomisiertes, placebo-kontrolliertes Studium konzipiert, das sich auf die Bewertung sowohl der Sicherheit als auch der Wirksamkeit von Allocetra™-Knieinjektionen konzentriert. Die Studie wird Gelenkschmerzen und Gelenkfunktion im Vergleich zum Placebo nach drei, sechs und zwölf Monaten nach der Behandlung bewerten. Die erste Dosierung zeigte keine Sicherheitsbedenken.
- Successful progression from Phase I to Phase II trial stage
- Independent Data and Safety Monitoring Board recommended proceeding with highest tested dose
- No safety concerns reported in initial Phase II dosing
- Trial designed to evaluate both short-term and long-term efficacy (up to 12 months)
- None.
Insights
The initiation of the Phase II stage for Allocetra in knee osteoarthritis represents a significant milestone, though investors should maintain measured expectations. The trial's progression to randomized, placebo-controlled testing following successful safety data is encouraging, but several key considerations remain:
Key Analysis Points:
- The study is designed to evaluate both short-term (3 months) and long-term (12 months) outcomes, providing comprehensive efficacy data
- The focus on both joint pain and function as endpoints aligns with FDA requirements for osteoarthritis treatments
- The market opportunity is substantial - osteoarthritis affects over 32.5 million adults in the US alone
- However, the small market cap of
$26.7M suggests significant risk factors, including potential funding needs for later-stage development - Competition in the osteoarthritis space is intense, with multiple treatment approaches in development
Nes-Ziona, Israel, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the enrollment and dosing of the first 10 patients in the randomized Phase II stage of the Company’s multi-country Phase I/II Allocetra™ trial in patients with moderate to severe knee osteoarthritis. The initiation of patient dosing follows the recently announced recommendation by the independent Data and Safety Monitoring Board to proceed with the randomized Phase II stage at the highest tested dose, as well as the Danish Medicines Agency’s authorization to initiate this next trial stage.
The multi-center Phase I/II clinical trial consists of two stages. The first stage, which was successfully completed, was 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. In addition to evaluating safety, the blinded randomized stage is statistically powered to assess the efficacy of Allocetra™ injections into the knee. The trial’s key efficacy end points 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 highly committed to executing our clinical programs in accordance with our projected timelines. The first 10 patients in the double-blind, randomized, placebo-controlled Phase II stage of the study successfully started their course of intra-articular knee injections. No safety concerns were recorded following the initial dosing. Osteoarthritis is the most prevalent form of arthritis and is a leading cause of adult chronic pain and long-term disability. Currently there are no commercially available drugs proven to arrest or reverse progression of this disease, and we are hopeful that the novel mechanism of action of AllocetraTM will change the way we treat these patients.”
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 timelines for completing current clinical studies, market opportunities for the results of current clinical studies and preclinical experiments, and 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 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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