OrthoTrophix, Inc., a privately held biopharmaceutical company, announced today that TPX-100 treatment is associated with significant decreases in MRI-based structural pathology in knee OA compared with placebo. These results, from a randomized, double-blind, placebo-controlled Phase 2 trial, correlate significantly with striking improvements in patient reported clinical benefits. The data are presented in two posters at the American College of Rheumatology (ACR/ARP) Annual Meeting in Atlanta, GA.
Three-dimensional (3D) changes in the femur have been shown to predict onset and progression of knee OA, as well as the need for total knee replacement. As detailed in the first presentation, TPX-100-treated knees demonstrated a significant reduction in pathological 3D shape change in the femur among subjects with moderate to severe tibiofemoral osteoarthritis (TFOA). This reduction was seen at both 6 and 12 months in knees treated with a single series of 4 intra-articular injections of TPX-100 compared with placebo-exposed knees. These reductions in bone shape change were associated with clinically meaningful and statistically significant improvements in knee physical function.
In the second presentation, the effect of TPX-100 on 3D shape changes in the patella was demonstrated among subjects with patello-femoral OA, with or without TFOA. At 12 months after the 4-injection series, TPX-100-treated knees showed a significant reduction in pathological patellar shape change compared with placebo-exposed knees. Clinically, pain frequency in TPX-100-treated knees decreased, on average, from daily to 1-2 times monthly in responders. Knee pain has been more strongly associated with severity of patello-femoral OA than with that of central compartment (tibiofemoral) OA. The benefits in pain frequency reduction correlated significantly with reductions in patellar bone shape change in TPX-100-treated knees.
TPX-100 is the only candidate disease-modifying osteoarthritis drug, to our knowledge, to show a strong correlation between structural and clinical benefits in a controlled clinical trial when compared to placebo,” commented Dr. Dawn McGuire, OrthoTrophix’ Chief Medical Officer. “The concordance of positive, robust clinical outcomes with a significant slowing of bone pathology suggests that TPX-100 is disease modifying, both in terms of joint structure and in disease symptoms that afflict and disable patients with knee OA.”
The company is scheduled to make two presentations as follows:
- Abstract 1303 entitled Intra-Articular TPX-100 Significantly Delays Pathological Bone Shape Change at 6 and 12 Months in Moderate to Severe Tibiofemoral OA at poster session for 9:00 “ 11:00am on Monday, November 11th.
- Abstract 2192 entitled Stabilization of Patellar Bone-Shape Correlates Significantly with Reduced Knee Pain Frequency after IA TPX-100 in Subjects with Bilateral Patellofemoral OA at poster session for 9:00 “ 11:00am on Tuesday, November 12th.
About OrthoTrophix, Inc.
OrthoTrophix, Inc., based in Oakland, California, is a privately held biopharmaceutical company focused on development and commercialization of a new class of Disease Modifying Osteoarthritis Drug (DMOAD). Founded by three co-founders in 2011, the primary focus of OrthoTrophix has been regeneration and repair of cartilage and underlying bones in the knee and other joints with its novel proprietary compounds.
This press release contains forward-looking statements. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development and cannot be guaranteed. OrthoTrophix undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect OrthoTrophix business.
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