Previous analysis demonstrated robust and statistically significant clinical benefits of the drug in moderate to severe knee OA.
| OAKLAND, Calif., May 13, 2019 /PRNewswire/ -- OrthoTrophix, Inc., a privately-held biopharmaceutical company, announced today 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. About OrthoTrophix, Inc. OrthoTrophix, Inc., based in Oakland, California, is a privately held biopharmaceutical company focused on the development and commercialization of revolutionary therapeutics for the treatment of diseases and conditions involving the hard tissues. Founded by three co-founders in 2011, the primary focus of OrthoTrophix has been regeneration and repair of cartilage in the knee and other joints with its novel proprietary compounds which promote formation of new cartilage and bone tissues and thereby repair the respective defects. 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. Company Contact
SOURCE OrthoTrophix, Inc. |
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