Business & Finance
Clinical Benefits of TPX-100 in Knee Osteoarthritis Patients are Associated with Improvements in Knee Cartilage Structure Modification
15 August 2018 - - US-based biopharmaceutical company OrthoTrophix, Inc has presented results of a post-hoc responder analysis of the Phase 2 clinical study with TPX-100, the company's osteoarthritis 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.

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.

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 USD 30m from its preferred stock financing and research and development revenues since its inception.