Sep 21, 2021, 06:21 ET
FOSTER CITY, Calif., Sept. 21, 2021 /PRNewswire/ -- OrthoTrophix, Inc., a privately held biopharmaceutical company, announced today that the Company and its collaborators have published a new research article presenting clinical data demonstrating disease modification in knee osteoarthritis (OA) patients treated with TPX-100, the Company's leading candidate for a Disease Modifying Osteoarthritis Drug (DMOAD).
The article entitled, "Study TPX-100-5: intra-articular TPX-100 significantly delays pathological bone shape change and stabilizes cartilage in moderate to severe bilateral knee OA" was published online by Arthritis Research & Therapy on September 17th (https://doi.org/10.1186/s13075-021-02622-8).
In this study, TPX-100-treated knees demonstrated a statistically significant decrease in pathological bone shape change in the femur compared with placebo-treated knees and the reduced pathological bone shape change showed statistically significant correlation with medial and total tibiofemoral cartilage thickness stabilization (p<0.01). This is the first time that a potential therapy showed a significant effect on three-dimensional (3D) bone shape. Combined with statistically significant and clinically meaningful improvements in knee function vs. placebo, as previously reported, these data support TPX-100 as a candidate drug for disease modification in knee OA, one of the most disabling afflictions in the US and worldwide.
"To our best knowledge, TPX-100 is the only DMOAD candidate that has demonstrated clinically meaningful and statistically significant clinical benefits as compared to placebo, along with structural improvements in the basic OA joint pathology that has been shown to be predictive of knee joint failure and knee replacement. Concordance between clinical and structural benefits is essential, per FDA guidance, for successful DMOAD development," commented Dr. Dawn McGuire, OrthoTrophix' Chief Medical Officer. "Our finding of 3D bone shape improvement and cartilage stabilization of the femur is especially impressive, as this the largest bone in the knee joint, critical for knee function. The evidence of disease modification by TPX-100 is strong, and we look forward to presenting additional data in upcoming conferences."
About OrthoTrophix, Inc.
OrthoTrophix, Inc., based in the San Francisco Bay Area, 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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