Doron Therapeutics has dosed the first patients in its Phase 3 clinical trial of MOTYS (PTP-001), an injectable biologic for the treatment of knee osteoarthritis. The global study aims to evaluate pain relief and functional improvement following a single administration of the therapy.

The company said MOTYS has received Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations from the US Food and Drug Administration (FDA), supporting its potential to address one of the most prevalent chronic conditions worldwide.

The Phase 3 trial follows a successful end-of-Phase 2 meeting with the FDA in May and will enrol around 300 patients across multiple international sites. The randomised, placebo-controlled study will assess changes in pain and function for up to 12 months after a single injection.

Alessandra Pavesio, chief executive of Doron Therapeutics, said: “The initiation of our Phase 3 study represents a critical inflection point for Doron Therapeutics. We are advancing a highly differentiated therapy with the potential to address one of the largest areas of unmet need in medicine.”

Professor David Hunter, chair of rheumatology at the University of Sydney and Royal North Shore Hospital in Australia, and principal investigator in the study, 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.”

Osteoarthritis of the knee is a leading cause of chronic pain and mobility loss, affecting hundreds of millions globally. There are currently no approved disease-modifying therapies, and treatment options focus largely on symptom management. MOTYS is designed to provide sustained pain relief and improve joint function, potentially filling a significant gap in current osteoarthritis care.