OrthoTrophix, Inc.

Clinical Benefits of TPX-100 in Knee Osteoarthritis Patients are Associated with Improvements in Knee Cartilage Structure Modification

Oakland, Calif., August 13, 2018—OrthoTrophix, Inc., a privately held biopharmaceutical company, announced today results of a post-hoc responder analysis of the Phase 2 clinical study with TPX-100, the company’s osteoarthritis (OA) drug candidate. The 55% of knees that responded to TPX-100 with clinically meaningful improvements in critical knee functions (KOOS Function in Daily Living) also demonstrated improvements in knee cartilage volume and thickness that were statistically significant. “Our responder analysis strongly suggests that the striking improvements in knee function in over half of TPX-100 treated knees are related to improvements in cartilage structure as measured by MRI,” commented OrthoTrophix’ Chief Medical Officer, Dr. Dawn McGuire.

OrthoTrophix presented primary results of 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 at the most recent American College of Rheumatology meeting (San Diego, November 2017). Clinically meaningful and statistically significant improvements in knee function were shown at both 6 and 12 months as measured by KOOS and WOMAC scales in knees treated with TPX-100 compared with placebo exposed knees.  In the (pre-defined) responder population for the key functional measure (KOOS Function in Daily Living), lateral tibiofemoral cartilage thickness and volume improved significantly at the 12-month end of study (p = 0.00007 and 0.0006, respectively). In animal models, TPX-100 has demonstrated articular cartilage repair after controlled cartilage injury in the knee joint.

“Clearly, the most desired effect of an osteoarthritis treatment is based on clinical benefits to afflicted patients. Our completed Phase 2 study of TPX-100 has shown such benefits. It is encouraging that knees responding to TPX-100 with improvements in function also show cartilage changes consistent with its structure modifying effects.”

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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