OrthoTrophix Initiated Phase 2b Clinical Trial of TPX-100 in Patients with Mild to Severe Knee Osteoarthritis

FOSTER CITY, Calif., May 12, 2025 /PRNewswire/ -- OrthoTrophix, Inc., a privately held biopharmaceutical company, today announced the initiation of a Phase 2b clinical trial of TPX-100, its lead therapeutic candidate, in patients with mild to severe knee osteoarthritis (OA) in the United States.

          TPX-100 is being developed as a potential disease-modifying osteoarthritis drug (DMOAD), a class of therapies that aim not only to alleviate symptoms but to slow or halt disease progression. In a prior randomized, placebo-controlled Phase 2a trial, TPX-100 demonstrated a favorable safety profile and produced clinically meaningful and statistically significant improvements in knee function compared to placebo. In addition, knees treated with TPX-100 exhibited reduced structural deterioration in the subchondral bone that supports the knee joint.

          While knee OA has long been viewed primarily as a cartilage disease, recent evidence, including findings from a natural history study involving over 9,000 knees, suggests that pathological changes in subchondral bone occur earlier and are key predictors of symptom progression, disease advancement, and eventual joint replacement. Post hoc MRI analyses from the Phase 2a study indicated that TPX-100 treatment significantly reduced these pathological bone-shape changes compared to placebo (McGuire et al., Arthritis Research & Therapy, 2021).

          The newly launched Phase 2b trial, titled "A 53-Week Study Evaluating the Safety and Efficacy of Intra-Articular Injections of TPX-100 in Patients with Mild to Severe Tibiofemoral Osteoarthritis of the Knee," is designed to confirm both the symptomatic improvements and structural effects observed in the earlier trial. Full study details are available at ClinicalTrials.gov under the identifier NCT06865079.

          Dawn McGuire, M.D., FAAN, Chief Medical Officer of OrthoTrophix, stated: "We were encouraged that the data supported the relationship between functional improvement and reduced pathological bone shape change observed in TPX-100-treated knees in our earlier study. This Phase 2b trial is a critical step toward validating TPX-100 as a potential first-in-class DMOAD. We are optimistic that these results could pave the way for a breakthrough in the treatment of knee osteoarthritis."

About OrthoTrophix, Inc.
OrthoTrophix, Inc., based in the San Francisco Bay Area, California, is a privately held biopharmaceutical company focused on development and commercialization of a first-in-class Disease Modifying Osteoarthritis Drug (DMOAD).  Founded by three co-founders in 2011, the primary interest of OrthoTrophix has been repair and regeneration of hard tissues to treat osteoarthritis and other hard tissue conditions.  OrthoTrophix partnered with American Regent, Inc. (https://americanregent.com/) on its DMOAD candidate, TPX-100, for the U.S. market and retains the rights for the rest of the world.

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.

Company Contact
Yoshi Kumagai
President and CEO
Tel:  (510) 488-3832

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SOURCE OrthoTrophix, Inc.