South Korea-based Dong-A ST announced that therapeutic equivalence and safety were established between DMB-3115 and Stelara (ustekinumab; Janssen Biotech), the reference drug, in global phase 3 trials. 

Stelara is indicated for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

DMB-3115 is a global phase 3 trial initiated in 2021, which enrolled 605 patients over 52 weeks in the US and eight European countries. 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. There was no clinically significant difference in safety, according to a Dong-ST news release.

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. In July 2021, Intas was 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.

“We will leverage the successful global phase 3 of DMB-3115 and submit the marketing authorization application for the US and the EU in the first half of 2023,” Min-young Kim, President & CEO os Dong-A ST, said in a company news release. "We are committed to supplying DMB-3115 to the global market at the earliest date possible through close cooperation with Intas Pharmaceuticals.”