Doron Therapeutics announced treatment of initial patients in its Phase III clinical trial of MOTYS, the company’s lead biologic candidate for the treatment of knee osteoarthritis. MOTYS has been granted FastTrack and Regenerative Medicine Advanced Therapy designations by FDA. The Phase III study of this investigational therapy follows the successful completion of an End-of-Phase II meeting held with FDA earlier this year.
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.
The 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.
“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.”
Doron Therapeutics announced treatment of initial patients in its Phase III clinical trial of MOTYS, the company’s lead biologic candidate for the treatment of knee osteoarthritis. MOTYS has been granted FastTrack and Regenerative Medicine Advanced Therapy designations by FDA. The Phase III study of this investigational therapy follows the...
Doron Therapeutics announced treatment of initial patients in its Phase III clinical trial of MOTYS, the company’s lead biologic candidate for the treatment of knee osteoarthritis. MOTYS has been granted FastTrack and Regenerative Medicine Advanced Therapy designations by FDA. The Phase III study of this investigational therapy follows the successful completion of an End-of-Phase II meeting held with FDA earlier this year.
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.
The 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.
“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.”
Copy to clipboard 
