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Doron Therapeutics successfully completed its initial RMAT and End-of-Phase 2 meeting with FDA for MOTYS (PTP-001), the company’s lead biologic candidate for the treatment of knee osteoarthritis (OA).
Key meeting outcomes include:
- Confirmation of size and scope of Phase 3 clinical program and associated safety database to support proposed indication in knee OA
- Confirmation of pivotal study design, including primary endpoint and key secondary endpoints, with valuable input provided by FDA on statistical analysis plan
- Alignment on plan for implementation of manufacturing changes and lot release specifications, with an emphasis on our proprietary disease-relevant methods for assessing drug potency, purity and identity
“We’re thrilled by the outcome of this meeting and with the Agency’s constructive feedback providing clear and actionable guidance on key elements of our Phase 3 program,” said MK Kottke, Head of Regulatory and CMC at Doron Therapeutics.
“With confirmation of our Phase 3 study design, including a clinically meaningful and statistically robust primary endpoint, we’re preparing for the start of our first Phase 3 study. This will be a multi-site, multi-national, placebo-controlled RCT involving approximately 300 patients and designed to evaluate improvements in both pain and function for up to 12 months after a single MOTYS injection,” said Alessandra Pavesio, Doron Therapeutics’ CEO. “The strength of our clinical evidence, coupled with regulatory alignment on our streamlined Phase 3 program, positions us to advance MOTYS as a potentially transformative therapy in a space where innovation has been lacking and long dominated by sub-optimal therapies.”
MOTYS is a terminally sterilized, off-the-shelf, regenerative biologic designed as an intra-articular knee injection for the management of symptomatic knee OA. MOTYS’ rigorously controlled and consistently potent secretome, growth factor and extracellular matrix components are derived from donated placental tissues following healthy at-term births. MOTYS was granted FastTrack and RMAT designations by FDA in January 2025.
MOTYS was initially developed as a key pipeline program at Bioventus, which was the sole investor in the MOTYS program during its early stages. In 2022, Bioventus decided to divest the MOTYS program due to financial constraints. Key management involved in the program negotiated an exclusive worldwide license for the technology and formed Doron Therapeutics in 2023. Doron Therapeutics is now an independent company, and Bioventus remains a minority shareholder.
Source: Doron Therapeutics
Doron Therapeutics successfully completed its initial RMAT and End-of-Phase 2 meeting with FDA for MOTYS (PTP-001), the company's lead biologic candidate for the treatment of knee osteoarthritis (OA).
Key meeting outcomes include:
Confirmation of size and scope of Phase 3 clinical program and associated safety database to support proposed...
Doron Therapeutics successfully completed its initial RMAT and End-of-Phase 2 meeting with FDA for MOTYS (PTP-001), the company’s lead biologic candidate for the treatment of knee osteoarthritis (OA).
Key meeting outcomes include:
- Confirmation of size and scope of Phase 3 clinical program and associated safety database to support proposed indication in knee OA
- Confirmation of pivotal study design, including primary endpoint and key secondary endpoints, with valuable input provided by FDA on statistical analysis plan
- Alignment on plan for implementation of manufacturing changes and lot release specifications, with an emphasis on our proprietary disease-relevant methods for assessing drug potency, purity and identity
“We’re thrilled by the outcome of this meeting and with the Agency’s constructive feedback providing clear and actionable guidance on key elements of our Phase 3 program,” said MK Kottke, Head of Regulatory and CMC at Doron Therapeutics.
“With confirmation of our Phase 3 study design, including a clinically meaningful and statistically robust primary endpoint, we’re preparing for the start of our first Phase 3 study. This will be a multi-site, multi-national, placebo-controlled RCT involving approximately 300 patients and designed to evaluate improvements in both pain and function for up to 12 months after a single MOTYS injection,” said Alessandra Pavesio, Doron Therapeutics’ CEO. “The strength of our clinical evidence, coupled with regulatory alignment on our streamlined Phase 3 program, positions us to advance MOTYS as a potentially transformative therapy in a space where innovation has been lacking and long dominated by sub-optimal therapies.”
MOTYS is a terminally sterilized, off-the-shelf, regenerative biologic designed as an intra-articular knee injection for the management of symptomatic knee OA. MOTYS’ rigorously controlled and consistently potent secretome, growth factor and extracellular matrix components are derived from donated placental tissues following healthy at-term births. MOTYS was granted FastTrack and RMAT designations by FDA in January 2025.
MOTYS was initially developed as a key pipeline program at Bioventus, which was the sole investor in the MOTYS program during its early stages. In 2022, Bioventus decided to divest the MOTYS program due to financial constraints. Key management involved in the program negotiated an exclusive worldwide license for the technology and formed Doron Therapeutics in 2023. Doron Therapeutics is now an independent company, and Bioventus remains a minority shareholder.
Source: Doron Therapeutics
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
