Levicept Reports Positive Phase II Trial Results for LEVI-04 in Treating Moderate to Severe Osteoarthritis

Levicept Ltd, a biotechnological firm dedicated to developing LEVI-04, has announced encouraging findings from its Phase II clinical trial for the novel and pioneering neurotrophin-3 (NT-3) inhibitor aimed at treating osteoarthritis and associated pain. The trial highlighted that LEVI-04 was both highly effective and well-tolerated.

The study was a multicenter, randomized, double-blind, placebo-controlled Phase II trial that included over 510 participants suffering from knee osteoarthritis. The trial sites were spread across Europe and Hong Kong, with Professor Philip Conaghan MD from the University of Leeds and Leeds Teaching Hospitals NHS Trust in the UK spearheading the research.

LEVI-04 achieved significant results compared to the placebo at Week 17 across all primary and secondary efficacy endpoints for all doses evaluated. The primary endpoint involved the WOMAC pain assessment, where the mean reduction in pain scores was over 50% for all three doses of LEVI-04, each statistically superior to the placebo. Secondary endpoints included WOMAC subscales for function and joint stiffness, patient global assessment, and daily pain scores, all of which also showed significant improvement over the placebo.

Safety assessments were thorough and indicated that LEVI-04 was well-tolerated. Importantly, there was no observed increase in the incidence of rapidly progressive osteoarthritis (RPOA), as determined through detailed radiographic analysis.

Levicept plans to submit the full results for publication in a peer-reviewed journal. Professor Conaghan remarked that the results are exceptional and clinically significant, emphasizing the need for safe and effective pain management in arthritis. He noted that current treatments have limitations such as adverse effects, addiction risks, and poor efficacy. LEVI-04, by inhibiting NT-3, has shown the potential to provide significant pain relief without these drawbacks. If the Phase III trials confirm these findings, LEVI-04 could represent a major advancement in osteoarthritis treatment and other pain conditions.

Globally, osteoarthritis affected approximately 595 million people in 2020, making it the most prevalent form of arthritis. The market for osteoarthritis treatments is estimated to exceed $10 billion. Simon Westbrook, the founder and Chief Scientific Officer of Levicept, explained that LEVI-04 was designed using evolutionary principles to supplement the body's natural NT regulator, soluble p75NTR. LEVI-04 offers pain relief by inhibiting NT-3 without the severe side effects associated with other treatments like anti-NGF antibodies. It also retains the beneficial effects of neurotrophins, such as joint remodeling.

Kevin Johnson, Chairman of Levicept and Partner at Medicxi, one of the founding investors, praised the strong Phase II results, affirming the belief in LEVI-04's potential as a breakthrough treatment for osteoarthritis. He indicated that Levicept is now in an excellent position to consider strategic options for advancing LEVI-04’s development.

LEVI-04 is a proprietary fusion protein that works by inhibiting NT-3 activity and restoring neurotrophin balance, thereby providing analgesia. Levicept Ltd, based in the UK, is pioneering this class of biological therapies for osteoarthritis and chronic pain. The company’s investors include Medicxi, Advent Life Sciences, Gilde Healthcare, and Pfizer Ventures.