Enlivex Receives Notice of Allowance for Chinese Patent Application Covering the Use of Allocetra in Patients with Osteoarthritis
Enlivex Therapeutics (Nasdaq: ENLV) has received a notice of allowance from China's CNIPA for patent application 2020800620493, covering the use of Allocetra™ in treating osteoarthritis patients. The patent, expected to be issued in H1 2025, will provide protection through 2040.
The company recently reported positive interim 6-month efficacy data from its Phase I/II Allocetra™ trial in moderate to severe knee osteoarthritis patients. Key results include:
- 47.0% average reduction in reported pain (P=0.0001) vs baseline
- 46% improvement in joint function
- 40% improvement in joint stiffness
- 83% of patients remained treatment responders after 6 months
- No serious adverse events reported
- Maintained positive effects observed at 3 months
Enlivex Therapeutics (Nasdaq: ENLV) ha ricevuto un avviso di concessione dalla CNIPA cinese per la domanda di brevetto 2020800620493, che copre l'uso di Allocetra™ nel trattamento dei pazienti affetti da osteoartrite. Il brevetto, che si prevede sarà rilasciato nella prima metà del 2025, offrirà protezione fino al 2040.
Recentemente, l'azienda ha riportato dati di efficacia intermedia positivi dopo 6 mesi dal suo trial di Fase I/II su Allocetra™ in pazienti con osteoartrite del ginocchio da moderata a grave. I risultati chiave includono:
- Riduzione media del 47,0% del dolore riportato (P=0,0001) rispetto al basale
- Miglioramento del 46% nella funzione articolare
- Miglioramento del 40% nella rigidità articolare
- Il 83% dei pazienti è rimasto rispondente al trattamento dopo 6 mesi
- Nessun evento avverso grave segnalato
- Effetti positivi mantenuti osservati a 3 mesi
Enlivex Therapeutics (Nasdaq: ENLV) ha recibido un aviso de concesión de la CNIPA de China para la solicitud de patente 2020800620493, que cubre el uso de Allocetra™ en el tratamiento de pacientes con osteoartritis. Se espera que la patente sea emitida en la primera mitad de 2025 y proporcionará protección hasta 2040.
Recientemente, la compañía informó datos interinos positivos de eficacia a 6 meses de su ensayo de Fase I/II de Allocetra™ en pacientes con osteoartritis de rodilla de moderada a severa. Los resultados clave incluyen:
- Reducción promedio del 47,0% en el dolor reportado (P=0,0001) en comparación con la línea base
- Mejora del 46% en la función articular
- Mejora del 40% en la rigidez articular
- El 83% de los pacientes permanecieron como respondedores al tratamiento después de 6 meses
- No se reportaron eventos adversos graves
- Efectos positivos mantenidos observados a los 3 meses
Enlivex Therapeutics (Nasdaq: ENLV)는 중국 CNIPA로부터 2020800620493 특허 신청에 대한 허가 통지를 받았습니다. 이는 Allocetra™를 사용하여 골관절염 환자를 치료하는 것을 포함합니다. 이 특허는 2025년 상반기에 발급될 것으로 예상되며, 2040년까지 보호를 제공합니다.
회사는 최근 중등도에서 중증 무릎 골관절염 환자를 대상으로 한 Allocetra™의 1/2상 시험에서 6개월간의 긍정적인 중간 효능 데이터를 보고했습니다. 주요 결과는 다음과 같습니다:
- 기저선 대비 보고된 통증의 평균 47.0% 감소 (P=0.0001)
- 관절 기능 46% 개선
- 관절 경직 40% 개선
- 6개월 후 83%의 환자가 치료 반응자로 남음
- 심각한 부작용 없음
- 3개월에서 관찰된 긍정적인 효과 유지
Enlivex Therapeutics (Nasdaq: ENLV) a reçu un avis de concession de la CNIPA de Chine pour la demande de brevet 2020800620493, couvrant l'utilisation de Allocetra™ dans le traitement des patients atteints d'arthrose. Le brevet, qui devrait être délivré au premier semestre 2025, offrira une protection jusqu'en 2040.
Récemment, la société a rapporté des données d'efficacité intermédiaires positives après 6 mois de son essai de Phase I/II sur Allocetra™ chez des patients atteints d'arthrose du genou modérée à sévère. Les résultats clés incluent :
- Réduction moyenne de 47,0 % de la douleur rapportée (P=0,0001) par rapport à la ligne de base
- Amélioration de 46 % de la fonction articulaire
- Amélioration de 40 % de la raideur articulaire
- 83 % des patients sont restés répondeurs au traitement après 6 mois
- Aucun événement indésirable grave signalé
- Effets positifs maintenus observés à 3 mois
Enlivex Therapeutics (Nasdaq: ENLV) hat eine Erlaubnisbenachrichtigung vom CNIPA in China für den Patentantrag 2020800620493 erhalten, der die Verwendung von Allocetra™ zur Behandlung von Patienten mit Osteoarthritis abdeckt. Das Patent, das voraussichtlich in der ersten Hälfte von 2025 erteilt wird, bietet Schutz bis 2040.
Das Unternehmen berichtete kürzlich über positive Zwischenresultate nach 6 Monaten aus seiner Phase I/II-Studie mit Allocetra™ bei Patienten mit moderater bis schwerer Knie-Osteoarthritis. Wichtige Ergebnisse umfassen:
- Durchschnittliche Schmerzlinderung von 47,0% (P=0,0001) im Vergleich zur Ausgangsbasis
- 46% Verbesserung der Gelenkfunktion
- 40% Verbesserung der Gelenksteifigkeit
- 83% der Patienten blieben nach 6 Monaten Behandlungsresponders
- Keine schwerwiegenden Nebenwirkungen berichtet
- Positive Effekte, die nach 3 Monaten beobachtet wurden, blieben erhalten
- Strong efficacy data with 47% pain reduction in osteoarthritis trial
- High patient response rate of 83% after 6 months
- Durable treatment effects maintained from 3 to 6 months
- Clean safety profile with no serious adverse events
- Patent protection in China secured until 2040
- Phase I/II trial still in early stages, final results pending
Nes-Ziona, Israel, March 17, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the China National Intellectual Property Administration (CNIPA) issued a notice of allowance for patent application number 2020800620493. Once issued, the resulting patent will provide Enlivex with added intellectual property protection in China through at least 2040 with claims covering methods of using Allocetra™ to treat subjects with osteoarthritis. The Company expects that this new patent will be issued in China during the first half of 2025.
Enlivex recently reported positive interim six (6) months efficacy data from the first stage of its ongoing randomized, multi-country Phase I/II Allocetra™ trial in patients with moderate to severe knee osteoarthritis.
Key highlights:
- Statistically significant,
47.0% average reduction of reported pain (P=0.0001), compared to average pain level at baseline 46% improvement in joint function and40% improvement in joint stiffness83% of the patients were still considered as responders to treatment1 after 6 months- No serious adverse events
- Efficacy continues to display strong persistence and durability over time, maintaining the 3-month positive effect
Oren Hershkovitz, Ph.D, CEO of Enlivex, commented, “We are very pleased to receive the first patent allowance for the use of AllocetraTM as a potential treatment in patients with osteoarthritis. We believe that this allowance provides high assurance that similar patent allowances will be obtained across all major jurisdictions as part of our IP portfolio rollout.”
ABOUT KNEE OSTEOARTHRITIS2
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
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1 According to the OMERACT-OARSI criteria (Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International)
2 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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