Enlivex Announces the Dosing of the First Patient in a Phase I Clinical Trial Evaluating Allocetra in Patients with Psoriatic Arthritis
Enlivex Therapeutics has initiated a Phase I clinical trial evaluating Allocetra™ in patients with psoriatic arthritis. The first patient has completed dosing and initial follow-up with no safety concerns reported. The trial aims to recruit six patients who haven't responded adequately to conventional therapies. The study will assess safety through monitoring adverse events, and measure changes in pain and disease activity for up to 12 months post-treatment. This trial complements Enlivex's ongoing osteoarthritis study, targeting high-grade inflammatory joint disease with potential market opportunities.
Enlivex Therapeutics ha avviato un trial clinico di Fase I per valutare Allocetra™ in pazienti con artrite psoriasica. Il primo paziente ha completato il trattamento e il primo follow-up senza segnalazioni di preoccupazioni per la sicurezza. Lo studio mira a reclutare sei pazienti che non hanno risposto adeguatamente alle terapie convenzionali. La ricerca valuterà la sicurezza monitorando gli eventi avversi e misurerà i cambiamenti nel dolore e nell'attività della malattia per un massimo di 12 mesi post-trattamento. Questo trial integra lo studio in corso di Enlivex sull'osteoartrite, mirato a patologie articolari infiammatorie di alto grado con potenziali opportunità di mercato.
Enlivex Therapeutics ha iniciado un ensayo clínico de Fase I para evaluar Allocetra™ en pacientes con artritis psoriásica. El primer paciente ha completado la dosis y el seguimiento inicial sin que se hayan reportado preocupaciones de seguridad. El ensayo tiene como objetivo reclutar a seis pacientes que no han respondido adecuadamente a las terapias convencionales. El estudio evaluará la seguridad a través de la monitorización de eventos adversos y medirá los cambios en el dolor y la actividad de la enfermedad durante un período de hasta 12 meses después del tratamiento. Este ensayo complementa el estudio en curso de Enlivex sobre la osteoartritis, dirigido a enfermedades articulares inflamatorias de alto grado con potenciales oportunidades de mercado.
Enlivex Therapeutics는 건선 관절염 환자에서 Allocetra™를 평가하는 1상 임상 시험을 시작했습니다. 첫 번째 환자가 용량을 완료하고 초기 후속 관찰을 마쳤으며 안전성 문제는 보고되지 않았습니다. 이 시험은 기존 치료에 충분히 반응하지 않은 여섯 명의 환자를 모집하는 것을 목표로 합니다. 연구는 부작용을 모니터링하여 안전성을 평가하고 치료 후 최대 12개월 동안 통증과 질병 활동의 변화를 측정할 것입니다. 이번 시험은 고등급 염증성 관절 질환을 겨냥한 Enlivex의 진행 중인 골관절염 연구를 보완하며, 잠재적인 시장 기회를 제공합니다.
Enlivex Therapeutics a lancé un essai clinique de Phase I pour évaluer Allocetra™ chez des patients atteints d'arthrite psoriasique. Le premier patient a terminé le traitement et le suivi initial sans aucun problème de sécurité signalé. L'essai vise à recruter six patients qui n'ont pas répondu de manière adéquate aux thérapies conventionnelles. L'étude évaluera la sécurité en surveillant les événements indésirables et mesurera les changements dans la douleur et l'activité de la maladie jusqu'à 12 mois après le traitement. Cet essai complète l'étude actuelle d'Enlivex sur l'arthrose, ciblant les maladies articulaires inflammatoires de haut degré avec des opportunités de marché potentielles.
Enlivex Therapeutics hat eine Phase-I-Studie zur Bewertung von Allocetra™ bei Patienten mit psoriatischer Arthritis eingeleitet. Der erste Patient hat die Dosierung und die erste Nachbeobachtung ohne Sicherheitsbedenken abgeschlossen. Die Studie zielt darauf ab, sechs Patienten zu rekrutieren, die nicht ausreichend auf konventionelle Therapien angesprochen haben. Die Studie wird die Sicherheit durch die Überwachung von Nebenwirkungen bewerten und Änderungen der Schmerzen und der Krankheitsaktivität bis zu 12 Monate nach der Behandlung messen. Diese Studie ergänzt die laufende Osteoarthritis-Studie von Enlivex, die sich auf hochgradige entzündliche Gelenkerkrankungen fokussiert, die potenzielle Marktchancen bieten.
- First patient dosed successfully with no safety concerns
- Expansion into new therapeutic indication (psoriatic arthritis)
- Potential market opportunity in underserved treatment area
- Small trial size of only 6 patients
- Early-stage Phase I trial with long follow-up period (12 months)
Insights
The initiation of a Phase I trial for Allocetra™ in psoriatic arthritis represents an early-stage clinical development milestone, though with immediate market impact. The key points include:
- The trial's small size (6 patients) indicates this is primarily a safety study
- The target population consists of patients who failed conventional therapies, addressing an unmet medical need
- The 12-month follow-up period means meaningful efficacy data won't be available for an extended time
The expansion into psoriatic arthritis, alongside the ongoing osteoarthritis trial, shows pipeline diversification into inflammatory joint diseases. However, given the early stage and small scale, this news has minimal immediate impact on company valuation or near-term prospects. Success in this trial would primarily serve as a proof-of-concept for Allocetra™ in high-grade inflammatory conditions.
Nes-Ziona, Israel, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the completion of the dosing and initial follow-up period for the first patient in its Phase I clinical trial evaluating the safety, tolerability and potential therapeutic effect of Allocetra™ following injection into an affected joint in patients with psoriatic arthritis. No safety concerns were recorded following the dosing of the first patient.
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™.
Dr. Oren Hershkovitz, CEO, commented, “Complementing our ongoing clinical trial in osteoarthritis, which is a low-grade chronic inflammatory joint disease, this new study provides an opportunity to assess Allocetra™ in a high-grade inflammatory joint disease such as psoriatic arthritis, which is another indication with poor treatment alternatives that we believe potentially presents a substantial market opportunity for 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
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
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 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
FAQ
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