OrthoTrophix, Inc. announced new analyses from a Phase 2 study of TPX-100, the company’s osteoarthritis (OA) drug candidate. The new results indicate slowing or halting of pathological bone shape changes, findings that support structural disease modification by TPX-100 treatment. Previous analysis demonstrated robust and statistically significant clinical benefits of the drug in moderate to severe knee OA.
Study TPX-100-5, entitled “Longitudinal Evaluation of Periarticular Bone Area and 3D Shape in Subjects with Bilateral Tibiofemoral Osteoarthritis Who Participated in Study TPX-100-1” measured longitudinal changes of the 3D (three-dimensional) shape of femoral bone using MRI images acquired from subjects participating in Study TPX-100-1. All bone shape analyses were performed in a blinded manner by international leaders in joint structure assessment for knee OA.
TPX-100-treated knees demonstrated a statistically significant delay in bone shape changes that have been associated with OA progression and risk of total knee replacement at both 6 and 12 months after treatment compared with placebo-treated knees. Data from the Osteoarthritis Initiative (OAI) indicates that longitudinal bone shape change is a more reliable predictor of OA progression than MRI measurements of cartilage thickness and volume in the knee. In addition to bone shape stabilization, TPX-100-treated knees showed clinically meaningful and statistically significant improvements in knee function and reduction in pain frequency as compared to placebo-treated knees, with an overall decrease in analgesic use of 62.5%.
“These findings suggest a structural benefit concordant with the striking clinical benefits demonstrated in our Phase 2 study of TPX-100. The drug was well-tolerated with no drug-related severe adverse events and no concerning safety issues. Based on these results, we believe TPX-100 is a first-in-class disease-modifying osteoarthritis drug and look forward to further development of this ground-breaking compound,” commented OrthoTrophix’ Chief Medical Officer, Dr. Dawn McGuire.
This article was republished without editing, using materials from OrthoTrophix’ press release.