Levicept Announces FDA Acceptance of IND Application for LEVI-04, a Potentially Disease-Modifying Treatment for Osteoarthritis

SANDWICH, United Kingdom, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis (OA), today announces the US Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for LEVI-04. This enables the initiation of further clinical development as a potentially disease-modifying treatment for osteoarthritis.

Levicept has completed a successful 518-participant Phase II study of LEVI-04 in patients with pain and disability due to OA of the knee (ClinicalTrials.gov ID: NCT05618782). Data presented at ACR Convergence, showed the primary endpoint of the trial was met with significant analgesia and symptom control across all doses, with a favourable safety and tolerability profile.

Further data analysis shared at ACR Convergence has shown that LEVI-04 had positive dose-dependent effects on the size and presence of bone marrow lesions, compared to placebo. Reduction in bone marrow lesions was significantly correlated with improvements in OA symptom scores, suggesting LEVI-04 may have disease modification properties in addition to the analgesic properties already reported.

Levicept is now planning for clinical studies in a broader participant population and to allow further data gathering on long-term dosing.

Eliot Forster, CEO of Levicept, said: “This new IND is an important step in our further development of LEVI-04 with the potential to treat millions of OA patients in need worldwide. We have already demonstrated LEVI-04 has a unique profile in its potential to significantly reduce pain and also directly address the disease process. We look forward to the next steps in our clinical programme and further building the data package around this important molecule.”

Levicept

Eliot Forster, CEO - eliot@levicept.com

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About Levicept – www.levicept.com

Levicept Ltd is a UK-based biotechnology company developing the first in a new class of novel, safe and efficacious biological therapies, LEVI-04 [p75NTR-Fc], for the treatment of osteoarthritis and chronic pain. LEVI-04 inhibits NT-3, one of the neurotrophin family of proteins. LEVI-04 has completed a Phase II clinical trial in more than 500 patients with osteoarthritis. It is estimated that the market opportunity for drugs that treat osteoarthritis is worth in excess of $10 billion. LEVI-04 was discovered by Levicept’s founder, Simon Westbrook. Levicept’s investors include Medicxi, Advent Life Sciences, Gilde Healthcare and Pfizer Ventures.

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