OAKLAND, Calif., Dec. 15, 2016 /PRNewswire/ -- OrthoTrophix, Inc., a privately held biopharmaceutical company, announced today the results of the first proof of principle study of TPX-100 in subjects with bilateral osteoarthritis (OA) of the knee.
The Phase 2 clinical trial was entitled, "A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects with Mild to Moderate Patello-Femoral Osteoarthritis Involving Both Knees."
The study was initiated in February 2014, and the last subject's last visit was completed in April 2016.
In this one-year study, 115 subjects with mild to moderate bilateral patello-femoral osteoarthritis received 4 weekly doses of TPX-100 by intra-articular administration in one knee and identical placebo injections in the other. Safety and tolerability of TPX-100 were excellent. While investigational MRI measures of cartilage thickness and volume showed no difference between drug and placebo-treated knees, the majority of standardized, patient-reported measures of knee daily function, quality of life and sports and recreation function as measured by the Knee injury and Osteoarthritis Outcome Scores (KOOS) demonstrated both statistically significant and clinically meaningful improvements in the TPX-100-treated knees as compared to the placebo-treated knees.
The Company's Chief Medical Officer, Dawn McGuire, M.D., FAAN stated, "We are very encouraged by the significant and sustained benefits in daily and recreational knee function and overall knee-related quality of life in knees treated with TPX-100. We anticipate that more advanced MRI measures may reveal structure-modifying effects of TPX-100 in subsequent trials, consistent with its effects on articular cartilage repair demonstrated in a large animal model. Improvements at 6 and 12 months in key knee-related outcome measures, ones associated with risk for knee replacement, suggest that TPX-100 improves joint health and may be able to prevent or delay the need for replacement surgery."
About OrthoTrophix, Inc.
OrthoTrophix, Inc., based in Oakland, Calif., 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 thereby repairing the respective defects. OrthoTrophix has received over $30 million from its equity financing and partnering revenues since its inception.
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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SOURCE OrthoTrophix, Inc.