Significant Improvements in Knee Function after TPX-100 Administration in a Double-Blind, Placebo-Controlled Phase 2 Study of Knee Osteoarthritis
Oakland, Calif., December 15, 2016—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.”
In this one-year study, 115 subjects with mild to moderate bilateral patello-femoral OA received 4 weekly doses of TPX-100 by intra-articular administration in one knee and identical placebo injections in the other. While the subjects were screened by their OA severity in the patello-femoral compartments, approximately 40% of all knees had severe (ICRS Grade 4) tibio-femoral OA at the baseline. Combining all compartments, all knees had at least one compartment with moderate to severe (ICRS Grade 2 – 4) OA, including approximately 80% with ICRS Grade 3 or 4 OA.
Safety and tolerability of TPX-100 were excellent. Efficacy measures include quantitative MRI assessments of patello-femoral cartilage thickness and volume, and validated measures of knee function and pain when engaged in various common and recreational activities. Less than 15% of subjects showed any measurable changes in cartilage thickness or volume in treated or control knees, and no differences were detected in the cartilage measures between the knees. In the whole study population, knee function was significantly improved in TPX-100-treated knees compared with controls. In multiple functional domains, these improvements were sustained out to 12-months after treatment. In addition, knee-related quality of life was significantly improved in TPX-100-treated knees compared with controls. These results were both statistically significant and clinically meaningful. While TPX-100 is not directly analgesic, pain when going up and down stairs, the most common complaint in knee OA, also was significantly improved in TPX-100-treated knees compared with controls.
The Company’s Chief Medical Officer, Dawn McGuire, M.D., FAAN stated, “We are very encouraged by the significant and sustained benefits in TPX-100-treated knees that were reported by subjects using standard, validated instruments such as the KOOS and WOMAC scales. Study subjects, all of whom suffered from moderate to severe OA, reported clinically meaningful improvements at 6 and 12 months in key areas of knee function, including those most associated with risk for knee replacement. Improved function and decreased pain in critical areas could translate into decreased need for invasive surgery.”
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. OrthoTrophix has received over $30 million from its preferred stock financing and research and development 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.
Company Contact
Yoshi Kumagai
President and CEO
Tel: (510) 488-3824
Fax: (510) 567-8785
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