OAKLAND, Calif.—OrthoTrophix, Inc., a privately held biopharmaceutical company, has announced that the company plans to report long-term clinical benefits in mild to severe knee osteoarthritis (OA) patients who were treated with TPX-100 at the 2018 OARSI annual meeting, held this year in Liverpool, U.K., from April 26 - 29.

 

OrthoTrophix previously presented the results of a Phase 2 clinical study in which the company’s OA drug candidate, TPX-100 improved knee function and physical quality of life at 6 and 12 months after treatment, compared with placebo. A follow-on protocol, TPX-100-4, assessed the same patient reported outcomes in subjects who participated in TPX-100-1.

 

The average time from the initial TPX-100 treatment was 30 months, with a range of 28 - 35 months. Exclusion criteria included knee surgery or investigational drugs for OA in the interim between TPX-100-1 and TPX-100-4. Of the 93 subjects in TPX-100-1, 53 enrolled in TPX-100-4. Topline results of this follow-on study will be included in the poster session of the 2018 OARSI annual meeting under the abstract entitled “TPX-100 Leads To Marked, Sustained Improvements In Subjects With Knee Osteoarthrits.”

 

The company’s Chief Medical Officer, Dawn McGuire, M.D., FAAN said, “The long-term follow-on study enrolled over half the TPX-100-1 subjects, despite being an observational study only. The sustained improvement in knee function for more than two years in knees injected with TPX-100 confirms our confidence in TPX-100 as a drug with the potential to modify the disease of knee osteoarthritis as patients actually experience it.”