Enlivex Begins Phase I Trial Dosing Allocetra for Psoriatic Arthritis

Nes-Ziona, Israel, Nov. 14, 2024 – Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage company focusing on macrophage reprogramming immunotherapy, has completed the dosing and initial follow-up period for the first patient in its Phase I clinical trial. This trial is evaluating the safety, tolerability, and potential therapeutic effect of Allocetra™ when injected into an affected joint in patients suffering from psoriatic arthritis. No safety concerns were observed following the initial dosing.

The trial aims to enroll six patients who have not responded adequately to conventional treatments for psoriatic arthritis. The primary endpoint of this study is to assess the frequency and severity of adverse events and serious adverse events. Secondary endpoints will evaluate changes from baseline in pain and other disease activity parameters over a period of up to 12 months following the administration of Allocetra™.

Dr. Oren Hershkovitz, CEO of Enlivex Therapeutics, highlighted the importance of this new study, stating, “In addition to our ongoing clinical trial in osteoarthritis, which is a low-grade chronic inflammatory joint disease, this new study offers an opportunity to evaluate Allocetra™ in a high-grade inflammatory joint disease like psoriatic arthritis. This condition has limited treatment options, and we believe it represents a significant market opportunity for Enlivex.”

Psoriatic arthritis (PsA) is a chronic inflammatory arthritis that generally occurs in individuals with psoriasis, a skin condition characterized by red, scaly patches. PsA can impact any joint in the body, causing pain, stiffness, and swelling. It can also lead to 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 estimates suggest the market will reach $20.5 billion by 2032, with a compound annual growth rate (CAGR) of 7.4% from 2024 to 2032. Other forecasts predict the PsA treatment market will 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 landscape of PsA treatment is fraught with challenges, including limited efficacy, side effects, high costs, long-term safety issues, underdiagnosis, and patient adherence problems. Addressing these challenges necessitates ongoing research and development of more effective, safer, and affordable treatments. Additionally, efforts to improve diagnosis and patient education are essential.

Enlivex is actively working on developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Restoring non-homeostatic macrophages to their balanced state is crucial for immune system rebalancing and the resolution of life-threatening and debilitating conditions.