Based on this double-blinded, placebo-controlled, multi-center study, data are presented from 93 subjects with bilateral knee OA who received 4 weekly doses of TPX-100 by intra-articular administration in one knee and identical placebo injections in the other, with at least one follow-up evaluation at 6 and 12 months. Knee injury and Osteoarthritis Outcome (KOOS) scores, and use of non-steroidal analgesics are presented. By way of background, pre-clinical data from earlier animal models are also presented, demonstrating articular cartilage formation in the knee after experimental cartilage injury in goats.
Of note, knee-related activities of daily living (KOOS ADL scores) were significantly improved in TPX-100-treated knees compared with placebo exposed knees (p = 0.008 at both 6 and 12 months). While TPX-100 has no direct analgesic activity, pain when going up and down stairs, the most common complaint in knee OA, was significantly improved (p = 0.004), in TPX-100-treated knees at 12 months. Subjects’ use of NSAIDs declined by over 60% during the study period compared to the pre-dosing period.
The Company’s Chief Medical Officer, Dawn McGuire, M.D. stated, “The robust and sustained improvements in knee function are notable, as is the excellent safety and tolerability profile of TPX-100. Pain alleviation was somewhat unexpected and reasonably can be attributed to improved joint function. We are planning a Phase 2/3 study to confirm these striking results.”
About OrthoTrophix, Inc.
OrthoTrophix, Inc., based in Oakland, California, is a privately held biopharmaceutical company focused on the development and commercialization of revolutionary therapeutics for the treatment of diseases and conditions involving the hard tissues. Founded by three co-founders in 2011, the primary focus of OrthoTrophix has been regeneration and repair of cartilage in the knee and other joints with its novel proprietary compounds which promote formation of new cartilage and bone tissues and thereby repair the respective defects. OrthoTrophix has received over $30 million from its preferred stock financing and research and development revenues since its inception.
This press release contains “forward-looking” statements. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development and cannot be guaranteed. OrthoTrophix undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect OrthoTrophix’ business.
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SOURCE OrthoTrophix, Inc.
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