Reduction in Pathological Bone Shape Change Correlates with Decreased Frequency of Knee Pain After TPX-100 Treatment

OAKLAND, Calif.--(BUSINESS WIRE)-- OrthoTrophix, Inc. (www.orthotrophix.com), a privately-held biopharmaceutical company, announced today new results from a Phase 2 study of the osteoarthritis drug TPX-100. In subjects with MRI-confirmed bilateral patellofemoral knee osteoarthritis (OA), TPX-100 treatment was associated with a statistically significant and clinically meaningful reduction in frequency of knee pain compared with placebo. A retrospective MRI-based analysis of three-dimensional bone shape change, a biomarker of OA disease progression, revealed reduced or stabilized patellar bone shape change in TPX-100-treated knees compared with placebo-exposed knees. Based on extensive data from the Osteoarthritis Initiative, bone shape change is more sensitive than cartilage thickness measures as a predictor of knee OA progression and joint failure. At 12 months, reduced patellar bone shape change in TPX-100-treated knees correlated significantly with reduced pain frequency (p<0.001). Bone shape analyses were performed by international leaders in joint structure assessment for knee OA, blind to treatment assignment and clinical data.

“Knee pain is the most common reason that patients with knee OA seek medical help,” commented OrthoTrophix’ Chief Medical Officer, Dr. Dawn McGuire. “The reduction in pain frequency after TPX-100 was robust and sustained in over 50% of knees treated with TPX-100: from “daily” to less than weekly at 12 months. In addition, overall analgesic use declined by more than 60%. Significant correlation between a key clinical benefit and reduced or stabilized joint pathology provides support for TPX-100 as a disease-modifying OA drug (DMOAD). We are excited by these findings and are enthusiastic about further development of TPX-100 as a first-in-class treatment for patients afflicted with knee OA.”

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.

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