TPX-100: OrthoTrophix Presents More Evidence for Disease Modification in Knee Osteoarthritis in a New Abstract Published in Osteoarthritis & Cartilage Journal

Oakland, Calif., May 12, 2020—OrthoTrophix, Inc., a privately held biopharmaceutical company, announced today that the Company has demonstrated more evidence for disease modification in knee osteoarthritis (OA) patients treated with TPX-100, the Company’s leading candidate for a Disease Modifying Osteoarthritis Drug (DMOAD).

An abstract entitled, “Study TPX-100-5: Significant Reduction in Femoral Bone Shape Change 12 Months after IA TPX-100 Correlates with Tibiofemoral Cartilage Stabilization” was published on page S37-S38 in the April 2020 Supplemental Issue of Osteoarthritis and Cartilage (Abstract Number 32). The abstract was scheduled to be presented as a podium presentation on May 1 at the 2020 OARSI World Congress on Osteoarthritis, which was cancelled for the coronavirus pandemic.

In this study, three-dimensional (3D) shapes of the femur in knees of OA patients were measured with MRI at baseline (before treatment) and 6 and 12 months after treatment. As previously reported, pathological 3D shape changes in the femur in TPX-100-treated knees were significantly reduced as compared to placebo-treated knees. As now reported, the reduced pathological 3D shape changes in the femur were significantly correlated with stabilization of tibiofemoral cartilage thickness in the TPX-100-treated knees (p<0.01), but not in placebo-treated knees.

As reported previously, TPX-100-treated knees also demonstrated clinically meaningful and statistically significant improvement in critical knee functions as compared to placebo-treated knees, which correlated significantly with tibiofemoral cartilage stabilization. Collectively, these data indicate both structural and clinical benefits of TPX-100 in OA knees.

“TPX-100 has shown concordant, positive results in imaging markers and in clinical outcomes. The key dots have been connected,” commented Dr. Dawn McGuire, OrthoTrophix’ Chief Medical Officer. “Femoral bone shape change has been shown to predict OA onset, progression and the need for knee replacement. Our clinical data suggest that reducing pathological femoral bone shape change and stabilizing knee cartilage go hand in hand with functional improvements for patients. In addition, we previously showed that a robust reduction in knee pain frequency after TPX-100 correlates with reduced patella bone shape changes. These data provide further support for TPX-100 as a disease modifying drug for knee OA.”

About OrthoTrophix, Inc.

OrthoTrophix, Inc., based in Oakland, California, is a privately held biopharmaceutical company focused on development and commercialization of a new class of Disease Modifying Osteoarthritis Drug (DMOAD). Founded by three co-founders in 2011, the primary focus of OrthoTrophix has been regeneration and repair of cartilage and underlying bones in the knee and other joints with its novel proprietary compounds.

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

# # #