Levisept, a biotechnology company focused on the development of Levi-04, a first-in-class treatment for osteoarthritis (OA), presented key data from its phase 2 study of Levi-04 in patients with pain and disability due to OA of the knee at the European Alliance of Associations for Rheumatology (EULAR) conference held in London earlier this month.
This included analysis suggesting Levi-04 may be acting to modify disease in OA. Bone marrow lesions, detectable on MRI and representing areas of increased bone turnover, oedema and fibrosis, are a common feature of OA and associated with greater disease burden. Significant, dose-dependent reductions in BML presence and area were observed for Levi-04 versus placebo. BML area was also associated with patient-reported symptom outcome scores.
In addition, professor Philip Conaghan MBBS PhD, director NIHR Leeds Biomedical Research Centre, chief investigator of the study, presented a comparison of joint safety outcomes, compared to an anti-NGF phase 2 study of comparable duration (fasinumab), further differentiating Levi-04’s mechanism of action (NT-3 inhibition) from that of the anti-NGFs.
Levicept’s Levi-04 trial was a multi-arm, International, multicentre, randomised, double-blind, placebo-controlled, phase 2 study which enrolled 518 participants with pain and disability due to OA of the knee.
