•   First study of AllocetraTM in psoriatic arthritis, a chronic inflammatory condition that causes joint pain, swelling and stiffness, affects as many as 30% of people with psoriasis1, and has limited treatment options

NES-ZIONA, Israel I July 23, 2024 I 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 $10.8 billion in 2023, is estimated to grow substantially. Certain projections indicate the market will reach $20.5 billion by 2032, growing at a compound annual growth rate (CAGR) of 7.4% from 2024 to 2032. Other analysis anticipates 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 marked by significant challenges, including limited efficacy, side effects, high costs, long-term safety concerns, underdiagnosis, and issues with patient adherence. Addressing these challenges requires ongoing research and development of more effective, safer, and affordable treatments, along with efforts to improve diagnosis and patient education.


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.

SOURCE: Enlivex