Enlivex Therapeutics Ltd Reports Sustained Pain Reduction in Phase IIa Knee Osteoarthritis Trial

Enlivex Therapeutics Ltd. (NASDAQ: ENLV) announced on 24 November 2025 that its Phase IIa randomized, multi‑country Phase I/II Allocetra trial (ENX‑CL‑05‑001) has achieved positive six‑month topline data in patients with moderate to severe knee osteoarthritis (OA). The results confirm the durability of the therapy’s analgesic effect and demonstrate meaningful improvements in joint function in a clearly defined age‑related primary OA responder cohort.

Trial Design and Population

The trial enrolled a diverse, clinically relevant cohort of patients with primary, age‑related knee OA. Participants received allogeneic macrophage reprogramming therapy and were followed through a 24‑week period, with the primary endpoint focused on pain reduction and functional improvement. The six‑month analysis included the entire study population, providing a comprehensive view of the therapy’s efficacy over time.

Key Findings

  • Pain Reduction: The treatment produced a durable, clinically meaningful decline in pain scores that persisted through week 24, matching and extending the positive trend observed at the three‑month mark.
  • Improved Function: Functional assessments—measured by validated joint‑function scales—showed statistically significant gains, indicating that the therapy not only lessens pain but also enhances mobility and quality of life for patients.
  • Responder Identification: The data reaffirm the existence of an age‑related primary OA responder subgroup, underscoring the potential for precision treatment strategies within the broader OA population.

Scientific Context

The study was led by Professor Philip Conaghan, a globally recognized authority in osteoarthritis and musculoskeletal imaging. His involvement, along with the participation of the NIHR Leeds Biomedical Research Centre, lends robust scientific credibility to the findings. The confirmation of sustained benefit over 24 weeks strengthens the case for Enlivex’s macrophage‑reprogramming platform as a viable therapeutic avenue for OA—a disease burden that continues to rise worldwide.

Market Impact

Following the announcement, Enlivex’s shares rallied in the trading session, reflecting investor confidence in the data. The positive six‑month topline bolsters the company’s valuation trajectory, which, as of 20 November 2025, stood at a market cap of approximately $21.8 million USD with a closing price near $0.90 per share. The recent 52‑week high of $2.10 and low of $0.83 demonstrate a healthy price range that may be revisited as the company advances its clinical pipeline.

Forward‑Looking Perspective

Enlivex’s results reinforce the therapeutic potential of allogeneic macrophage reprogramming in managing osteoarthritis pain and functional decline. The company’s ongoing Phase III studies and strategic collaborations position it to capitalize on the unmet need in OA therapeutics. Continued clinical success could propel Enlivex into a new era of growth, expanding its footprint beyond OA into other inflammatory and immune‑mediated conditions.

The information herein is based on the company’s public statements and recent financial reporting. It is intended solely for informational purposes and should not be construed as investment advice.