Clinical Trials

Biotechnology company Levicept has announced positive results from its phase 2 trial into LEVI-04 for the treatment of osteoarthritis.

LEVI-04 is a proprietary p75 neurotrophin receptor fusion protein (p75NTR-Fc) that provides analgesia via inhibition of NT-3 activity and returns neurotrophin homeostasis by supplementing the endogenous p75NTR binding protein to scavenge excess neurotrophins present in chronic pain states. LEVI-04 demonstrated a reduction of greater than 50% in the WOMAC pain score for all three doses given.

The trial, led by Professor Philip Congahan, included over 510 participants who have pain and disability due to knee osteoarthritis, and was carried out in sites across Europe and Hong Kong.

Professor Philip Conaghan MD, director NIHR Leeds Biomedical Research Centre and principal investigator, said, “These results are truly exceptional and clinically meaningful in their extent. Safe and effective pain management is of critical importance in arthritis, with existing treatments limited by adverse effects, addiction liabilities and poor efficacy. In this trial, LEVI-04 has demonstrated the potential to safely harness the analgesic properties of neurotrophin-3 inhibition and offer a vital new treatment option to millions of patients in huge need. If phase 3 trials replicate these results, LEVI-04 would represent a major break-through for osteoarthritis treatment, and with substantial potential in other pain indications.”

Kevin Johnson, chairman of Levicept and partner at founding investor Medicxi said, “The results from this robust and large-scale phase 2 fully validate the belief of Levicept’s founders and investors that LEVI-04 could be a genuine breakthrough in the treatment of osteoarthritis. They also leave Levicept exceptionally well-positioned to consider the next strategic options to advance LEVI-04’s development.”