OrthoTrophix Inc, based in Oakland, Calif, reports that it has completed all enrollment and scheduled dosing in its Phase 2 clinical study of TPX-100 in subjects with bilateral osteoarthritis of the knee. In a company news release, it explains that it is developing TPX-100 as what it reports to be the first disease-modifying osteoarthritis drug.
The study—titled, “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”—was initiated in early 2014, and 115 subjects have completed all scheduled intra-articular injections, according to the company. Per the release, the last subject’s last visit to the clinical site is scheduled in April 2016, and the study results are expected in mid-2016.
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, OrthoTrophix explains in the release.
In the release, Dawn McGuire, MD, FAAN, the company’s chief medical officer, states, “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.”
She continues, “We look forward to 1-year data in order to assess the efficacy of TPX-100 in knee cartilage repair and regeneration.”
[Source(s): OrthoTrophix Inc, PR Newswire]