Reports confirm that OrthoTrophix, Inc., a privately held biopharmaceutical company, has recently announced that its TPX-100 therapy is associated with substantial reductions in MRI-based structural pathology in knee osteoarthritis (OA) as compared to placebo. These results are from a double-bind, randomized, placebo-controlled Phase 2 clinical trial.
The results significantly correlate with remarkable improvements in patient reported clinical benefits. The data are shown in two posters at the American College of Rheumatology Annual Meeting in Atlanta, GA.
Apparently, in the first presentation, the TPX-100-treated knees showed a considerable reduction in pathological 3D shape change in the femur among subjects with modest to severe tibiofemoral osteoarthritis. This reduction was noticed at both 6 and 12 months in knees treated with a single series of four intra-articular TPX-100 injections in comparison with placebo-exposed knees.
These kind of reductions in bone shape change were related with statistically important and medically meaningful improvements in knee physical function. Sources familiar with the matter informed that in the second presentation, the result of TPX-100 on 3D shape change in the patella was shown among studies with patello-femoral OA, with or without tibiofemoral osteoarthritis (TFOA).
In 12 months after 4-injection series, knees treated with TPX-100 demonstrated a substantial decrease in pathological patellar shape change as compared to placebo-exposed knees. Medically, the frequency of pain in TPX-100-treated knees reduced, on an average, from each day to 1-2 times monthly in responders. The advantages in pain frequency reduction are associated considerably with decreases in patellar bone shape change in TPX-100-treated knees.
According to Dr. Dawn McGuire, Chief Medical Officer of OrthoTrophix, TPX-100 is the first candidate disease-modifying osteoarthritis medicine, to demonstrate a robust correlation between clinical and structural benefits in a controlled clinical trial as compared to placebo.
The concordance of positive, strong clinical results with a considerable slowdown of bone pathology indicates that TPX-100 is disease modifying, both with regard to mutual structure and also in disease symptoms that affect and disable people with knee OA.
Source Credits: http://www.orthotrophix.com/news/2019/110919.html