OrthoTrophix, Inc., a privately held biopharmaceutical company, announced today that the Company started a Phase 2 clinical study of its cartilage repair therapeutic agent, TPX-100, with knee osteoarthritis patients in the U.S.The Company also announced that it had successfully closed the second and last tranche of its Series A preferred stock financing.
The purpose of the Phase 2 clinical trial is to obtain a proof of principle of the safety and knee cartilage repair efficacy of TPX-100 in mild to moderate knee osteoarthritis. The study 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 outline of the study is being posted at the ClinicalTrials.gov site.
OrthoTrophix plans to develop TPX-100 as the first disease modifying osteoarthritis drug, or DMOAD. Osteoarthritis, or OA, also known as degenerative joint disease, is the most common disease of the joints, and one of the most widespread of all chronic diseases. In the US, it is estimated that more than 27 million people suffer from osteoarthritis, including more than half of those individuals 65 years of age or older. While any joint could be affected by OA, knee is the most affected joint by the symptomatic OA, involving severe pain and loss of function. It is believed that the main cause of such symptoms are degeneration of articular cartilage in the joints by aging, mechanical stress, or both, and that repair of such damaged cartilage with new articular cartilage tissue would mitigate such symptoms. While its mortality is low, OA presents one of the most critical quality of life problems in all generation with much higher prevalence in the aged population.
TPX-100 was discovered as a tissue-specific hard tissue regeneration molecule. TPX-100 has demonstrated to repair cartilage, bone, and dentin defects by regenerating the respective tissues without affecting soft tissues, and without forming non-relevant tissues in the target site. For instance, TPX-100 forms only cartilage in the cartilage defects without forming bone or dentin tissues there. TPX-100 has demonstrated to promote regeneration of new articular (hyaline) cartilage in the cartilage defects in the knee joints and delay advancement of cartilage damage in multiple cartilage trauma and osteoarthritis models. TPX-100 has been tested in one Phase 1 and two Phase 2 clinical trials to date, and exhibited an excellent safety profile.
The Company's Chief Medical Officer, Dawn McGuire, M.D., FAAN stated, "A novel DMOAD that promotes articular cartilage formation by simple intraarticular injections would be a revolutionary advance for OA. Current treatments require invasive surgeries or else address only symptoms. We expect to modify the root cause of disability in OA."