- Global phase III with 605 patients from the US and eight European countries demonstrates therapeutic equivalence and safety between Stelara and DMB-3115
- Aims to submit marketing authorization in the first half of 2023 for the US and the EU
SEOUL, South Korea--(BUSINESS WIRE)--#DMB3115--Dong-A ST (President and CEO: Min-young Kim) (KRX:170900) announced on January 16th that therapeutic equivalence and safety were established between DMB-3115 and Stelara, the reference drug, in global phase III.
Stelara is a blockbuster drug developed by Janssen Biotech Inc. and indicated for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis; it recorded USD 16.8 billion (IQVIA, MAT Sept 2022) sales worldwide, making it one of the highest grossing biologic medicines.
DMB-3115 global phase III first kicked off in the US back in 2021 and then in eight European countries, including Poland, Estonia, and Latvia, with a total patient number of 605 over 52 weeks. Patients with moderate to severe chronic plaque psoriasis were treated with DMB-3115 or Stelara PFS to compare efficacy, safety, and immunogenicity. The trial was performed as a randomized, double-blinded, multicenter, parallel, and active-control study.
In accordance with the recommendation from the regulatory agencies, primary endpoint time frames were set as Week 8 and Week 12 for the EMA and the FDA, respectively.
DMB-3115 and Stelara demonstrated therapeutic equivalence when looking at percent change from baseline in PASI (Psoriasis Area and Severity Index) at Week 8 and Week 12. Similarly, there was no clinically significant difference in safety.
As the results are met for their differing recommendation of EMA and the FDA, the data is expected to be received more positively when submitted for marketing authorization to the respective agencies.
Dong-A Socio Holdings and Meiji Seika Pharma began joint development for DMB-3115 in 2013, and the rights of Dong-A Socio Holdings for R&D and commercialization were transferred to Dong-A ST in July 2020 for efficient project management; since then, Dong-A ST and Meiji Seika Pharma worked together for the development of the drug.
In July 2021, Dong-A ST and Meiji Seika Pharma signed a global license agreement with Intas, a leading multinational pharmaceutical company, and granted the exclusive rights for regulatory approval and commercialization of DMB-3115 in the territories excluding Korea, Japan and some Asian countries. DMB-3115 will be commercialized by Intas through its worldwide affiliates including Accord Biopharma in the US and Accord Healthcare in Europe, the UK and Canada. Dong-A ST and Meiji Seika Pharma are responsible for R&D and supply of the product to Intas and its worldwide affiliates.
Binish Chudgar, Vice-Chairman & Managing Director of Intas Pharmaceuticals, said, "This agreement with Dong-A ST and Meiji Seika Pharma emphasizes our commitment to acquiring advanced research to leverage our leadership position internationally. Further supporting our dedication to drive our mission of making world-class drugs more accessible to patients, globally."
Min-young Kim President & CEO Dong-A ST, said, “We will leverage the successful global phase III of DMB-3115 and submit the marketing authorization application for the US and the EU in the first half of 2023,” and continued, “We are committed to supplying DMB-3115 to the global market at the earliest date possible through close cooperation with Intas Pharmaceuticals.”
Dong-A ST CO., Ltd