Enlivex Announces Positive Interim Efficacy Data from Allocetra Trial in Patients with Moderate to Severe Knee Osteoarthritis
Enlivex Therapeutics announced positive interim efficacy data from its Phase I/II Allocetra™ trial for moderate to severe knee osteoarthritis. The Phase I stage showed statistically significant results (p-value < 0.0007, n=12) with marked improvements in key efficacy endpoints. The treatment demonstrated a 50% reduction in average knee joint pain, 42% improvement in knee joint function, and 37% reduction in knee joint stiffness after three months. Among participants, 83% were responders to Allocetra™, showing >40% pain reduction from baseline. The trial is now enrolling patients for the Phase II stage, which is double-blind, randomized, and placebo-controlled.
Enlivex Therapeutics ha annunciato dati intermedi positivi sull'efficacia del suo studio Allocetra™ di fase I/II per l'osteoartrite del ginocchio da moderata a grave. La fase I ha mostrato risultati statisticamente significativi (p-value < 0.0007, n=12) con notevoli miglioramenti nei principali endpoint di efficacia. Il trattamento ha dimostrato una riduzione del 50% del dolore medio alle articolazioni del ginocchio, un miglioramento del 42% nella funzionalità dell'articolazione del ginocchio e una riduzione del 37% della rigidità dell'articolazione del ginocchio dopo tre mesi. Tra i partecipanti, l'83% ha risposto a Allocetra™, mostrando una riduzione del dolore superiore al 40% rispetto al basale. Lo studio sta ora reclutando pazienti per la fase II, che è in doppio cieco, randomizzato e controllato con placebo.
Enlivex Therapeutics anunció datos interinos positivos sobre la eficacia de su ensayo Allocetra™ de fase I/II para la osteoartritis de rodilla moderada a severa. La fase I mostró resultados estadísticamente significativos (valor p < 0.0007, n=12) con mejoras notables en los principales puntos finales de eficacia. El tratamiento demostró una reducción del 50% en el dolor medio de la articulación de la rodilla, una mejora del 42% en la función de la articulación de la rodilla y una reducción del 37% en la rigidez de la articulación de la rodilla después de tres meses. Entre los participantes, el 83% respondió a Allocetra™, mostrando una reducción del dolor superior al 40% respecto a la línea base. El ensayo está reclutando pacientes para la fase II, que es doble ciego, aleatorizado y controlado con placebo.
Enlivex Therapeutics는 중등도에서 중증의 무릎 골관절염을 위한 Allocetra™의 1상/2상 임상 시험에서 긍정적인 중간 효능 데이터를 발표했습니다. 1상 단계에서 통계적으로 유의미한 결과가 나타났습니다(p-value < 0.0007, n=12) 주요 효능 지표에서 뚜렷한 개선이 있었습니다. 치료는 무릎 관절의 평균 통증에서 50% 감소, 무릎 관절 기능에서 42% 개선, 무릎 관절 강직에서 37% 감소를 보여주었습니다. 참가자 중 83%가 Allocetra™에 반응하였으며, 기준치 대비 40% 이상의 통증 감소를 보였습니다. 현재 임상 시험은 이중 맹검, 무작위 배정 및 위약 대조의 2상 단계에 환자를 모집하고 있습니다.
Enlivex Therapeutics a annoncé des données intermédiaires positives sur l'efficacité de son essai Allocetra™ de phase I/II pour l'arthrose du genou modérée à sévère. La phase I a montré des résultats statistiquement significatifs (valeur p < 0.0007, n=12) avec des améliorations marquantes dans les principaux critères d'efficacité. Le traitement a montré une réduction de 50 % de la douleur moyenne au genou, une amélioration de 42 % de la fonction du genou et une réduction de 37 % de la raideur du genou après trois mois. Parmi les participants, 83 % ont répondu à Allocetra™, montrant une réduction de la douleur supérieure à 40 % par rapport à la ligne de base. L'essai recrute maintenant des patients pour la phase II, qui est en double aveugle, randomisée et contrôlée par placebo.
Enlivex Therapeutics hat positive Zwischenwirksamkeitsdaten aus seiner Phase I/II-Studie Allocetra™ zur moderaten bis schweren Kniearthrose bekannt gegeben. Die Phase-I-Studie zeigte statistisch signifikante Ergebnisse (p-Wert < 0.0007, n=12), mit deutlichen Verbesserungen bei den wichtigsten Wirksamkeitsendpunkten. Die Behandlung zeigte eine 50%ige Reduzierung der durchschnittlichen Schmerzen im Kniegelenk, eine 42%ige Verbesserung der Funktion des Kniegelenks und eine 37%ige Reduzierung der Steifheit des Kniegelenks nach drei Monaten. Unter den Teilnehmern waren 83% Responder auf Allocetra™, mit einer >40%igen Schmerzlinderung gegenüber dem Ausgangswert. Die Studie rekrutiert jetzt Patienten für die Phase II, die doppelblind, randomisiert und placebokontrolliert ist.
- Statistically significant pain reduction of 50% in knee joint pain
- 42% improvement in knee joint function
- High responder rate of 83% showing >40% pain reduction
- No serious adverse reactions reported in Phase I
- Successfully completed Phase I safety run-in phase
- None.
Insights
The interim Phase I data for Allocetra in knee osteoarthritis demonstrates compelling efficacy with 50% reduction in pain and 42% improvement in knee function at 3 months post-treatment. The 83% responder rate and strong statistical significance (p<0.0007) are particularly noteworthy in this difficult-to-treat condition.
The positive safety profile combined with these efficacy signals positions Allocetra as a potential breakthrough in osteoarthritis treatment, where current options are to symptom management. With a $32.5 billion addressable market in the US alone, successful development could transform Enlivex's market position. However, investors should note these are early-stage results from an open-label trial - the ongoing double-blind Phase II portion will be important for validating these promising signals.
Nes-Ziona, Israel, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced positive interim efficacy data from the Phase I stage of its randomized, multi-country Phase I/II Allocetra™ trial in patients with moderate to severe knee osteoarthritis.
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 Company previously announced that no serious adverse reactions were reported during or following treatment in the Phase I stage. The information below details the interim efficacy data with respect to the treatment of these patients, measured three months following the administration of Allocetra™ injections. The interim efficacy results are highly positive, statistically significant (p-value < 0.0007, n=12), and show marked improvements in all key efficacy endpoints, including reduction of pain and an improvement in functionality, compared to baseline.
| Pre-Treatment | Three Months | Average Reduction (%)1 | Statistical Significance | |
| Average knee joint pain Scale 0 (no pain) to 10 (highest pain level) | 6.10 | 2.94 | p<0.0007 | |
| Low-High pain range of the group (Median) | 4.71 – 8.20 (5.43) | 0.14 – 6.29 (2.49) | NA | NA |
| Average knee joint function2 Scale 0-10 | 4.7 | 2.83 | p<0.0008 | |
| Average knee joint stiffness2 Scale 0-10 | 5.4 | 3.23 | p<0.003 |
| Responders to AllocetraTM | Non-Responders AllocetraTM | |
| Change from baseline Pain at 3 months > |
Einat Galamidi, MD, Medical Vice President of Enlivex, commented, “Osteoarthritis is the most prevalent form of arthritis and is a leading cause of adult chronic pain and long-term disability, affecting more than 32.5 million Americans. Currently there are no commercially available drugs proven to arrest or reverse progression of the disease. These interim results may indicate that the novel mechanism of action of AllocetraTM may provide a treatment alternative for these osteoarthritis patients.”
The trial is currently enrolling patients into the Phase II stage, which is a double-blind, randomized, placebo-controlled trial. 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 post treatment.
ABOUT KNEE OSTEOARTHRITIS5
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, 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 Percent reduction calculated per patient and then averaged for all patients.
2 Function and stiffness were assessed via Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire.
3 A lower score corresponds to higher function and lower stiffness, as applicable, and is indicative of a better response to treatment.
4
5 Source: The Arthritis Foundation, Disease modification in osteoarthritis; pathways to drug approval, Katz et. Al., Osteoarthritis and Cartilage Open (2) (2020)
FAQ
What were the key efficacy results of Enlivex's (ENLV) Allocetra trial for knee osteoarthritis?
What is the current stage of Enlivex's (ENLV) Allocetra osteoarthritis trial?
How many patients showed significant response to Allocetra in ENLV's osteoarthritis trial?
