— Global Trial to Assess Injectable Biologic Therapy for Pain Relief and Functional Improvement in Patients with Knee Osteoarthritis —

Doron Therapeutics, a clinical-stage biotechnology company developing novel biologics for musculoskeletal diseases, today announced that the initial patients have been dosed in its Phase 3 clinical trial of MOTYS (PTP-001), the company’s lead biologic candidate for the treatment of knee osteoarthritis. MOTYS has been granted FastTrack and Regenerative Medicine Advanced Therapy (RMAT) designations by the U.S. Food and Drug Administration (FDA). The Phase 3 study of this investigational therapy follows the successful completion of an End-of-Phase 2 meeting held with the FDA in May.

“The initiation of our Phase 3 study represents a critical inflection point for Doron Therapeutics,” said Alessandra Pavesio, Chief Executive Officer of Doron Therapeutics. “We are advancing a highly differentiated therapy with the potential to address one of the largest areas of unmet need in medicine. We believe MOTYS, our innovative drug designed to deliver prolonged relief from pain and restored mobility in osteoarthritis patients, is well-positioned to create meaningful and durable clinical benefit for this underserved and growing population.”

Professor David Hunter, Chair of Rheumatology at the University of Sydney and Royal North Shore Hospital, Australia, and Principal Investigator in the Phase 3 trial added, "Osteoarthritis remains the leading cause of pain and disability worldwide, yet treatment options for people living with this disease are woefully limited. This trial is an important step toward a biologic therapy that could transform care and bring real hope to millions of patients."

The Phase 3 study is a randomized, placebo-controlled trial enrolling approximately 300 patients across multiple sites and countries, with the goal of evaluating improvements in both pain and function for up to 12 months following a single MOTYS injection.

About MOTYS

MOTYS is Doron Therapeutics’ investigational biologic therapy designed as an off-the-shelf, intra-articular knee injection to address the complex underlying biology of osteoarthritis. MOTYS' rigorously controlled and consistently potent secretome, growth factor, and extracellular matrix components are derived from donated placental tissues, following healthy at-term births. The therapy is designed to display a multifactorial mechanism of action that promotes a beneficial combination of anti-inflammatory, anti-catabolic and pro-anabolic effects. By targeting key pathways involved in inflammation and tissue damage, MOTYS has the potential to provide both immediate and long-lasting relief to patients from a single injection. MOTYS is currently in Phase 3 clinical development and has not been approved for sale by any regulatory authority.

About Doron Therapeutics

Doron Therapeutics is a clinical-stage biotechnology company headquartered in Chapel Hill, North Carolina, dedicated to developing innovative biologic therapies for musculoskeletal diseases. To learn more, please visit: https://dorontherapeutics.com/.

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Doron Therapeutics Announces First Patients Dosed in Phase 3 Study of MOTYS (PTP-001) for the Treatment of Osteoarthritis of the Knee