Enlivex Therapeutics announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for Allocetra, the company’s macrophage‑reprogramming therapy, for use in patients with moderate‑to‑severe age‑related primary knee osteoarthritis.
Allocetra works by resetting macrophages to a homeostatic state, a mechanism that has shown promise in early studies. The IND clearance follows positive interim data from a Phase 1/2a trial, which demonstrated a statistically significant and durable reduction in pain and improvement in joint function at six months in older patients with knee osteoarthritis.
The clearance enables Enlivex to launch a global, multicenter, randomized, double‑blind, placebo‑controlled Phase IIb trial. The study will enroll patients with moderate‑to‑severe knee osteoarthritis and will evaluate safety and efficacy of intra‑articular Allocetra injections, with primary endpoints focused on pain, physical function, quality of life, and mobility at three and six months.
Knee osteoarthritis is a major unmet medical need, affecting millions worldwide and currently lacking disease‑modifying treatments. The market for knee osteoarthritis therapies is substantial and projected to grow, making a successful Phase IIb trial a potentially transformative development for Enlivex’s pipeline.
Enlivex’s strategy combines clinical development of Allocetra with a dual‑engine value creation model that includes a treasury‑token program. The company recently completed a $212 million private placement, maintains a strong liquidity position with a current ratio of 6.43 and a debt‑to‑equity ratio of 0.04, and plans to voluntarily delist from the Tel Aviv Stock Exchange to focus on U.S. capital markets.
"We are very pleased to have received FDA clearance to initiate the Phase IIb clinical trial," said Enlivex CEO Oren Hershkovitz. The clearance marks a critical advance in the company’s clinical development program and is expected to accelerate the path toward potential market entry for its osteoarthritis therapy.
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