Comparative evaluation of efficacy, safety, and immunogenicity with original subcutaneous injections
Dong-A ST (CEO Um Dae-sik) announced on the 25th that it has received approval from the US Food and Drug Administration (FDA) for phase 3 clinical trials of’DMB-3115′, which is being developed as a treatment for chronic plaque psoriasis.
DMB-3115 is a biosimilar of’Stellara (ingredient Ustekinumab)’ developed by Janssen.
Stellara is a biopharmaceutical that inhibits the activation of inflammatory cells by blocking the p40 subunit of the immune mediators interleukin (IL)-12 and interleukin (IL)-23. It is a treatment for inflammatory diseases such as plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
Stellara is a blockbuster product that recorded 7 trillion won in sales based on IQVIA data in 2019.
Dong-A Socio Holdings and Meiji Seika Pharma have been promoting joint development of DMB-3115 since 2013. In July of last year, the right to development and commercialization was transferred to Dong-A ST for efficient global project execution, and Dong-A ST and Meiji Seika Pharma are jointly developing.
DMB-3115 has been preclinical in Europe and Korea in 2018, and phase 1 clinical trials are underway to compare and evaluate the pharmacokinetic properties of DMB-3115 and Stellar in healthy adults in Europe from November 2019.
This global phase 3 clinical trial is conducted for moderate to severe chronic plaque psoriasis patients using clinical samples produced by DM Bio, a subsidiary of Dong-A Socio Holdings.
In order to compare the efficacy, safety, and immunogenicity of DMB-3115 and Stellara subcutaneous injection, the clinical trial is conducted as a randomized, double-blind, multicenter, parallel comparison, and active control trial.
Dong-A ST plans to initiate phase 3 clinical trials in the US within the first quarter, and sequentially apply for phase 3 clinical trial plans in nine European countries.
In particular, Dong-A ST plans to release Stellar in September 2023 and July 2024 when its substance patents expire in the US and Europe after clinical completion in order to preoccupy the global market.
An official from Dong-A ST said, “We will supply biopharmaceuticals with excellent quality and economical efficiency to the world by successfully completing the global phase 3 clinical trial of DMB-3115.”
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