Levicept has reported Phase 2 clinical trial results for LEVI-04 in osteoarthritis, published in The Lancet, showing significant reductions in pain and improvements in patient function.

The randomized, double-blind, placebo-controlled study enrolled 518 patients with osteoarthritis of the knee and evaluated multiple dose levels of LEVI-04 against placebo.

The trial met its primary endpoint, demonstrating statistically significant improvements in WOMAC pain scores across all doses. Secondary endpoints, including stiffness, physical function and patient global assessment, also showed improvement compared to placebo.

Responder analysis indicated that more than half of treated patients experienced at least a 50% reduction in pain, with over a quarter reporting reductions of 75% or more.

Osteoarthritis remains one of the most common chronic conditions globally, with limited treatment options beyond symptom management, highlighting ongoing demand for therapies that can both relieve pain and modify disease progression.

Professor Philip Conaghan, chief investigator of the study, said: “The potential benefits of this treatment for patients are very significant. Osteoarthritis impacts on all aspects of people’s lives and there are limited therapy options currently to manage the symptoms.”

LEVI-04 was reported to be well tolerated, with similar rates of treatment-emergent adverse events observed in both treatment and placebo groups. The study also found no increase in joint-related safety concerns.

Further analysis presented at scientific meetings suggested dose-dependent effects on bone marrow lesions, indicating potential disease-modifying activity in addition to pain relief.

Simon Westbrook, founder and cso of Levicept, added: “As shown in The Lancet publication, LEVI-04 significantly reduces pain and symptoms of OA.”

The company said it will continue clinical development of LEVI-04, positioning the therapy as a potential option in a field where few treatments address both symptoms and underlying disease mechanisms.