OrthoTrophix, Inc.

OrthoTrophix Licensed TPX-100 to American Regent for the United States

Foster City, California, December 14, 2023—OrthoTrophix, Inc., a privately held biopharmaceutical company, announced today that the Company licensed its TPX-100 to American Regent, Inc., a New York based pharmaceutical company specialized in injectable therapeutic products. Under this license, American Regent, Inc. obtains an exclusive right to commercialize TPX-100 in human therapeutic field in the United States. OrthoTrophix retains all rights to TPX-100 outside of the United States.

TPX-100 is a candidate for a Disease Modifying Osteoarthritis Drug (DMOAD). In a prospective, double blind, randomized Phase 2 trial conducted in the United States, TPX-100 demonstrated clinically meaningful and statistically significant knee function improvement in mild to severe knee osteoarthritis (OA) as compared to placebo. TPX-100 also significantly reduced pathological changes of subchondral bones, associated with progression of OA, in treated knees compared with placebo, which was consistent with the robust improvements in knee function observed.

"This is a meaningful step toward success in advancing TPX-100 as a first-line treatment for knee osteoarthritis, and potentially the first DMOAD,” commented the Company’s President and CEO, Yoshi Kumagai. “American Regent, with its specialty in injection products, is an ideal commercial partner for this product.”

"The burden of knee OA is staggering," commented Dr. Dawn McGuire, OrthoTrophix' Chief Medical Officer. "It affects more than 350 million people worldwide and is a major cause of years lived with disability. We are thrilled to partner with American Regent in continuing development of TPX-100, and we look forward to bringing TPX-100 as a first-in-class therapeutic to afflicted patients."

Paul Diolosa, President and CEO of American Regent, added, “We are excited about our partnership with OrthoTrophix. This licensing agreement provides the potential for us to be the first product on the market that can improve the quality of life and condition for patients with osteoarthritis. It’s a testament to our continued focus on products that improve the well-being of our patients.”

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 focus of OrthoTrophix has been regeneration and repair of bone and cartilage to treat osteoarthritis and other hard tissue conditions.

About American Regent, Inc.

American Regent, Inc., a Daiichi Sankyo Group company, is an industry leading injectable manufacturer. For more than 50 years, American Regent has been committed to improving human and animal health by developing, manufacturing and supplying quality injectable products that healthcare providers rely on for their patients. For more than 20 years, American Regent has been a leader in IV iron therapy. Today, American Regent continues to build on their commitment to patients with a focus toward fulfilling unmet needs in healthcare and delivering innovative, accessible injectable products.

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) 488-3824


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