OrthoTrophix, Inc., a privately held biopharmaceutical company, announced today that the Company and its collaborators present clinical data strongly supporting joint bone shape change as part of a surrogate marker predictive of joint replacement in knee osteoarthritis (OA) patients.
An abstract entitled, “Improved WOMAC Physical Function is Associated with Slowed Pathological Bone Shape Change after TPX-100: Towards a Surrogate Marker for Virtual Knee Replacement?” was presented today in a Plenary Session of 2022 OARSI World Congress on Osteoarthritis in Berlin, Germany (Abstract 26 in Osteoarthritis and Cartilage Vol. 30 Suppl. S28–S29).
Functional impairment is a key risk factor for knee replacement even after adjusting for knee pain severity, based on the large NIH-sponsored Multicenter Osteoarthritis Study (the “MOST” study) involving over 5,500 knees. In the TPX-100-5, a Phase 2 study, placebo-treated knees with more advanced pathological joint bone shape change at baseline showed much faster progression of pathological bone shape change and poorer knee function at the end of the 12-month study period. In marked contrast, TPX-100-treated knees demonstrated reduction in pathological bone shape change and robust improvement of knee function through 12 months, regardless of severity at baseline. Consequently, both clinical (knee function) and structural (bone shape) efficacies of TPX-100 as compared to placebo were confirmed including in subjects with moderate to severe knee OA.
“The current FDA draft guidance indicates that a positive effect on an imaging marker of OA must be associated with avoidance or delay of the need for joint replacement, or must persuasively reduce deterioration of function and worsening of pain. This is a high bar,” commented Dr. Dawn McGuire, OrthoTrophix’ Chief Medical Officer. “However, the Multicenter Osteoarthritis Study findings and our clinical data collectively suggest that concordant improvements of bone shape change and clinical function could lead to a delay or elimination of the need for joint replacement surgery. These combined outcomes in structure and function could provide a ‘virtual joint replacement’ measure for the study of disease-modifying agents in individuals afflicted with knee OA.”
OrthoTrophix also will present an abstract entitled, “Intra Articular TPX-100 Significantly Improves Pain Measures and Slows Pathological Bone Shape Chage in Knee OA”. This presentation demonstrates clinically meaningful improvements in overall knee pain and in specific key pain parameters in moderate to severe knee OA, linked to significant reductions in pathological bone shape change (Abstract 254 in Osteoarthritis and Cartilage Vol. 30 S193).