Enlivex Receives Regulatory Authorization For The Initiation Of A Phase I Clinical Trial To Evaluate Allocetra In Patients With Psoriatic Arthritis
Enlivex Therapeutics (Nasdaq: ENLV) has received authorization from the Israeli Ministry of Health to initiate a Phase I clinical trial for Allocetra™ in patients with psoriatic arthritis. The trial aims to evaluate the safety and tolerability of Allocetra™ when injected into an affected joint. It plans to recruit six patients who have not responded adequately to conventional therapies.
The primary endpoint will assess the frequency and severity of adverse events, while secondary endpoints will measure changes in pain and disease activity for up to 12 months post-administration. This marks the first study of Allocetra™ in psoriatic arthritis, a chronic inflammatory condition affecting up to 30% of people with psoriasis. CEO Oren Hershkovitz expressed optimism about developing a potentially effective treatment option for patients with alternatives.
Enlivex Therapeutics (Nasdaq: ENLV) ha ricevuto l'autorizzazione dal Ministero della Salute israeliano per avviare un trial clinico di fase I per Allocetra™ in pazienti affetti da artrite psoriasica. Lo studio si propone di valutare la sicurezza e la tollerabilità di Allocetra™ quando iniettato in un'articolazione colpita. È previsto che vengano reclutati sei pazienti che non hanno risposto adeguatamente alle terapie convenzionali.
L'endpoint primario valuterà la frequenza e la gravità degli eventi avversi, mentre gli endpoint secondari misureranno i cambiamenti nel dolore e nell'attività della malattia fino a 12 mesi dopo la somministrazione. Questo rappresenta il primo studio di Allocetra™ nell'artrite psoriasica, una condizione infiammatoria cronica che colpisce fino al 30% delle persone con psoriasi. Il CEO Oren Hershkovitz ha espresso ottimismo riguardo allo sviluppo di una potenziale opzione terapeutica efficace per i pazienti con alternative.
Enlivex Therapeutics (Nasdaq: ENLV) ha recibido autorización del Ministerio de Salud de Israel para iniciar un ensayo clínico de fase I para Allocetra™ en pacientes con artritis psoriásica. El ensayo tiene como objetivo evaluar la seguridad y la tolerancia de Allocetra™ cuando se inyecta en una articulación afectada. Se planea reclutar a seis pacientes que no han respondido adecuadamente a las terapias convencionales.
El objetivo primario evaluará la frecuencia y gravedad de los eventos adversos, mientras que los objetivos secundarios medirán los cambios en el dolor y la actividad de la enfermedad hasta 12 meses después de la administración. Este es el primer estudio de Allocetra™ en artritis psoriásica, una condición inflamatoria crónica que afecta hasta al 30% de las personas con psoriasis. El CEO Oren Hershkovitz expresó optimismo sobre el desarrollo de una opción de tratamiento potencialmente eficaz para los pacientes con alternativas.
Enlivex Therapeutics (Nasdaq: ENLV)는 이스라엘 보건부로부터 1상 임상 시험을 시작할 수 있는 허가를 받았습니다. 이 시험은 건선 관절염 환자에게 Allocetra™를 투여하여 그 안전성과 내약성을 평가하는 것을 목표로 합니다. 시험은 기존 요법에 충분히 반응하지 않은 6명의 환자를 모집할 계획입니다.
주요 평가 지표는 부작용의 빈도와 심각도를 평가하며, 2차 평가 지표는 투여 후 최대 12개월 동안 통증과 질병 활동의 변화를 측정합니다. 이는 건선 관절염에서 Allocetra™에 대한 첫 연구로, 이는 건선 환자의 최대 30%에게 영향을 미치는 만성 염증 상태입니다. CEO Oren Hershkovitz는 대체 치료법이 없는 환자를 위한 잠재적으로 효과적인 치료 옵션 개발에 대한 낙관을 표명했습니다.
Enlivex Therapeutics (Nasdaq: ENLV) a reçu l'autorisation du Ministère de la Santé israélien pour lancer un essai clinique de phase I pour Allocetra™ chez des patients atteints d'arthrite psoriasique. L'essai vise à évaluer la sécurité et la tolérabilité d'Allocetra™ lorsqu'il est injecté dans une articulation affectée. Il est prévu de recruter six patients qui n'ont pas correctement répondu aux thérapies conventionnelles.
Le critère principal évaluera la fréquence et la gravité des événements indésirables, tandis que les critères secondaires mesureront les changements de douleur et l'activité de la maladie jusqu'à 12 mois après l'administration. Il s'agit de la première étude d'Allocetra™ dans l'arthrite psoriasique, une condition inflammatoire chronique qui touche jusqu'à 30 % des personnes atteintes de psoriasis. Le PDG Oren Hershkovitz a exprimé son optimisme quant au développement d'une option de traitement potentiellement efficace pour les patients n'ayant pas d'alternatives.
Enlivex Therapeutics (Nasdaq: ENLV) hat die Genehmigung des israelischen Gesundheitsministeriums erhalten, um eine Phase-I-Studie für Allocetra™ bei Patienten mit Psoriasis-Arthritis zu starten. Die Studie zielt darauf ab, die Sicherheit und Verträglichkeit von Allocetra™ bei Injektion in ein betroffenes Gelenk zu bewerten. Es ist geplant, sechs Patienten zu rekrutieren, die nicht ausreichend auf konventionelle Therapien angesprochen haben.
Der primäre Endpunkt wird die Häufigkeit und Schwere von unerwünschten Ereignissen bewerten, während die sekundären Endpunkte Veränderungen von Schmerz und Krankheitsaktivität bis zu 12 Monate nach der Verabreichung messen werden. Dies ist die erste Studie zu Allocetra™ bei Psoriasis-Arthritis, einer chronischen Entzündungskrankheit, die bis zu 30 % der Menschen mit Psoriasis betrifft. CEO Oren Hershkovitz äußerte Optimismus hinsichtlich der Entwicklung einer potenziell wirksamen Behandlungsoption für Patienten ohne Alternativen.
- Received regulatory authorization to initiate Phase I clinical trial for Allocetra™ in psoriatic arthritis
- Expanding potential applications of Allocetra™ to a new indication with treatment options
- Addressing an unmet medical need in psoriatic arthritis patients who respond poorly to existing treatments
- Early-stage clinical trial (Phase I) with focus only on safety and tolerability
- Small sample size of only six patients planned for the trial
- Long observation period of up to 12 months may delay progression to later-stage trials
Insights
The initiation of a Phase I clinical trial for Allocetra™ in treating psoriatic arthritis is a significant milestone for Enlivex Therapeutics. This trial marks the first step in evaluating a new therapeutic option for a condition with limited effective treatments. Psoriatic arthritis affects up to 30% of individuals with psoriasis and represents a substantial market if successful. The primary focus on safety and tolerability is expected for a Phase I trial, but the secondary endpoints concerning pain and disease activity will provide early insights into the potential efficacy of Allocetra™.
Given the chronic nature of psoriatic arthritis and the unmet need for effective treatments, positive results could lead to an expanded market opportunity for Enlivex. However, it's essential to note that Phase I trials primarily assess safety; thus, it's premature to predict market impact solely based on this authorization.
From a financial perspective, the authorization to begin this Phase I trial is a positive development for Enlivex Therapeutics. Biotechnology companies often see stock price movements tied closely to clinical trial progress. The announcement can bolster investor sentiment by demonstrating pipeline advancement and the potential opening of new revenue streams if the treatment proves successful.
However, investors should be cautious as early-stage trials involve significant risk. The trial's success in demonstrating safety and preliminary efficacy will be important for securing further funding and advancing to later stages, which will be more indicative of commercial viability.
Analyzing the market potential, the psoriatic arthritis drug market is currently dominated by biologics and DMARDs (disease-modifying antirheumatic drugs). Allocetra™ represents a novel approach with its macrophage reprogramming mechanism, which could differentiate it significantly if proven effective. The market for psoriatic arthritis is also growing, driven by increased diagnosis rates and a rising prevalence of psoriasis worldwide.
A successful Phase I trial would position Enlivex competitively, potentially attracting partnerships or licensing deals. However, market penetration will depend on subsequent trials confirming Allocetra™'s efficacy and safety, as well as regulatory approvals beyond Israel.
• First study of AllocetraTM in psoriatic arthritis, a chronic inflammatory condition that causes joint pain, swelling and stiffness, affects as many as
Nes-Ziona, Israel, July 23, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Israeli Ministry of Health has authorized the initiation of a Phase I clinical trial to evaluate the safety and tolerability of Allocetra™ following injection into an affected joint in patients with psoriatic arthritis.
The trial currently plans to recruit six patients who have insufficiently responded to conventional therapies for psoriatic arthritis. The primary safety endpoint will measure the frequency and severity of adverse events and serious adverse events, and secondary endpoints will include assessments of change from baseline in pain and other parameters of disease activity for up to 12 months following administration of Allocetra™.
“There are many psoriatic arthritis patients with poor response to existing treatments. The mode of action of AllocetraTM may become a new modality in treating these patients. We are pleased to announce the initiation of a new clinical program in psoriatic arthritis and are looking forward to commencing the study as a first step to our future development of a potentially effective treatment option for these patients” stated Oren Hershkovitz, Ph.D., CEO of Enlivex.
ABOUT PSORIATIC ARTHRITIS1
Psoriatic arthritis (PsA) is a chronic inflammatory arthritis that typically occurs in individuals with psoriasis, a skin condition characterized by red, scaly patches. PsA can affect any joint in the body, leading to pain, stiffness, and swelling. It can also cause inflammation in other parts of the body, including the eyes, heart, and gastrointestinal tract. The global market for psoriatic arthritis (PsA) treatments, valued at approximately
ABOUT ALLOCETRA™
Allocetra™ is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as sepsis, osteoarthritis’ psoriatic arthritis and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, and harnessing the healing power of these cells, Allocetra™ has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening and life-debilitating clinical indications that are defined as “unmet medical needs,” as a stand-alone therapy or in combination with leading therapeutic agents.
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 http://www.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
1 https://www.yalemedicine.org/conditions/psoriatic-arthritis
https://www.reportsandinsights.com/report/psoriatic-arthritis-psa-treatment-market
https://www.snsinsider.com/reports/psoriatic-arthritis-treatment-market-3223
FAQ
What is the purpose of Enlivex's (ENLV) new Phase I clinical trial for Allocetra™?
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What are the endpoints of Enlivex's (ENLV) Phase I trial for Allocetra™ in psoriatic arthritis?
When did Enlivex (ENLV) receive authorization for the Allocetra™ psoriatic arthritis trial?
