OrthoTrophix Presents Knee Cartilage Structure Modification Data of TPX-100 at American College of Rheumatology Annual Meeting

OAKLAND, Calif., Oct. 23, 2018 /PRNewswire/ -- OrthoTrophix, Inc., a privately held biopharmaceutical company, announced today that the company and its collaborators presented the Phase 2 clinical study data of TPX-100 demonstrating structural improvement of knee cartilage associated with robust knee function improvement in knee osteoarthritis (OA) patients at the American College of Rheumatology (ACR/ARHP) Annual Meeting in Chicago, IL.

In a podium presentation entitled "Intra-Articular TPX-100 in Knee Osteoarthritis: Robust Functional Response at 6 and 12 Months is Associated with Increased Tibiofemoral Cartilage Thickness", Dawn McGuire, M.D., the company's Chief Medical Officer, reviewed recent data from Study TPX-100-1. Knee function and tibiofemoral (TF) cartilage structure changes at 12 months were analyzed in 68 bilateral TF OA subjects.  All subjects had International Cartilage Repair Society (ICRS) grade 2 – 4 TF OA at baseline, with 75% (51 subjects) having ICRS grade 3 – 4 (moderate to severe) OA in both knees.  The subjects received TPX-100 in one knee and placebo in the other knee as randomly assigned in four weekly intra-articular injections. The study subjects, site and sponsor were blinded to treatment assignment.

Knee function as measured by Knee injury and Osteoarthritis Outcome Scores (KOOS) and Western Ontario and McMaster Universities Osteoarthritis Score (WOMAC) at 6 and 12 months demonstrated clinically meaningful and statistically significant improvement of critical knee functions in TPX-100-treated knees as compared to placebo-exposed knees.  Approximately 65% of the TPX-100-treated knees achieved a clinically meaningful functional improvement at 6-months, 12-months, or both time points, which was also statistically significant as compared to placebo-exposed knees.  These responder knees also demonstrated statistically significant improvement in cartilage thickness in both medial and lateral TF compartments at 12 months as compared to the non-responders.

"I believe this is the first time that any experimental or commercial OA drug has demonstrated both clinically meaningful, statistically significant knee function improvement as well as statistically significant knee cartilage structure improvement.  In addition, overall physical quality of life, measured by Veterans RAND-12 Physical Component Score (VR-12 PCS), was significantly improved in association with knee functional response. Improvements of function and overall physical status of OA patients are our primary goals in our drug development program. These data indicate that the clinical benefits are linked to knee cartilage structure improvement, and suggest a disease and structure-modifying effect of TPX-100 on tibiofemoral knee OA," 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.  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

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SOURCE OrthoTrophix, Inc.