OrthoTrophix, Inc., has completed subject enrollment and all scheduled dosing in its Phase 2 clinical study of TPX-100 in subjects with bilateral osteoarthritis of the knee. 115 subjects have completed all scheduled intra-articular injections. The last subject's last visit of the clinical site is scheduled in April 2016, and the study results are expected in mid-2016.
OrthoTrophix is developing TPX-100 as the first disease modifying osteoarthritis drug (DMOAD). Osteoarthritis s among the most common of all disabling diseases. In the US, it is estimated that more than 27 million people suffer from osteoarthritis, including more than half of individuals 65 years of age or older. The knee is the joint most affected by symptomatic OA, and is one of the most important causes of poor quality of life in the aging population.
The Phase 2 clinical trial is entitled, "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." The study is designed to obtain proof of principle of safety and efficacy of TPX-100 for knee cartilage repair and regeneration compared to placebo among subjects with mild to moderate osteoarthritis. The study outline is posted at the ClinicalTrials.gov site.
The Company's Chief Medical Officer, Dawn McGuire, M.D., FAAN stated, "We have 18 clinical sites executing the study with rigor and enthusiasm. We are encouraged that enrollment has been quite efficient, and that all 115 subjects have completed dosing with excellent safety and tolerability. We look forward to one-year data in order to assess the efficacy of TPX-100 in knee cartilage repair and regeneration."