Here are five things to know about the study and company:
1. The company announced the beginning of the clinical study in February. The purpose of the phase 2 clinical trial is to obtain a proof of the safety and knee cartilage repair efficacy of TPX-100 in mild to moderate knee osteoarthritis.
2. The 27 subjects in the four dosing cohorts have completed all scheduled intra-articular injections. There have been no severe or serious adverse events, and no subjects have withdrawn from the trial.
3. OrthoTrophix is developing TPX-100 as the first disease modifying osteoarthritis drug. It has demonstrated the ability 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.
4. “It is encouraging that all subjects completed all scheduled TPX-100 administrations uneventfully, with no withdrawals or serious adverse events. Safety and tolerability of TPX-100 has been excellent at all four doses administered. We look forward to acquiring further safety and efficacy data on TPX-100 for the indication of articular cartilage repair and regeneration in patients afflicted by OA,” said the company’s CMO Dawn McGuire, MD.
5. Based in Oakland, Calif., OrthoTrophix is a privately held biopharmaceutical company focusing on the development and commercialization of revolutionary therapeutics for the treatment of diseases and conditions involving the hard tissues.
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