Enlivex Gets Approval for Phase I Trial of Allocetra in Psoriatic Arthritis

Enlivex Therapeutics Ltd., a clinical-stage company specializing in macrophage reprogramming immunotherapy, has received approval from the Israeli Ministry of Health to initiate a Phase I clinical trial for Allocetra™ in patients with psoriatic arthritis. This chronic inflammatory condition, affecting approximately 30% of individuals with psoriasis, often results in joint pain, swelling, and stiffness. Psoriatic arthritis has limited treatment options available, underscoring the significance of this new trial.

The trial aims to recruit six patients who have not responded adequately to traditional therapies for psoriatic arthritis. The primary objective is to assess the safety and tolerability of Allocetra™ when injected directly into an affected joint. The study will monitor the frequency and severity of adverse events and serious adverse events. Additionally, secondary endpoints will evaluate changes in pain levels and other disease activity parameters for up to 12 months post-administration of Allocetra™.

Dr. Oren Hershkovitz, CEO of Enlivex, expressed optimism about the trial, stating, “There are many psoriatic arthritis patients with poor response to existing treatments. The mode of action of Allocetra™ 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.”

Psoriatic arthritis (PsA) is a chronic inflammatory condition that typically occurs in individuals with psoriasis, characterized by red, scaly skin patches. PsA can affect any joint in the body, leading to significant 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 PsA treatments was valued at approximately $10.8 billion in 2023 and is projected to grow significantly. Some forecasts suggest the market could reach $20.5 billion by 2032, with a compound annual growth rate (CAGR) of 7.4% from 2024 to 2032. Other analyses predict an increase from $9.97 billion in 2023 to $24.87 billion by 2031, representing a CAGR of 12.1% from 2024 to 2031.

The current treatment landscape for PsA is fraught with challenges, including limited efficacy, side effects, high costs, long-term safety concerns, underdiagnosis, and patient adherence issues. Addressing these challenges requires continuous research and development of more effective, safer, and affordable treatments, along with efforts to enhance diagnosis and patient education.

Allocetra™ is being developed as a universal, off-the-shelf cell therapy intended to reprogram macrophages back to their homeostatic state. Various diseases, including sepsis, osteoarthritis, and psoriatic arthritis, disrupt macrophage homeostasis, contributing to disease severity. By restoring macrophage homeostasis, Allocetra™ aims to provide a novel immunotherapeutic mechanism of action for serious and debilitating clinical conditions that are considered unmet medical needs. This therapy could function as a stand-alone treatment or in combination with leading therapeutic agents.

Enlivex, the company behind Allocetra™, is dedicated to developing this universal cell therapy to reset non-homeostatic macrophages, which is crucial for rebalancing the immune system and resolving life-threatening and debilitating conditions.