Dong-A ST Receives US Approval for Phase 3 Clinical Trial of Psoriasis Biosimilar Treatment

[Asia Economy Reporter Lee Chun-hee] Dong-A ST announced on the 25th that its chronic plaque psoriasis treatment under development, 'DMB-3115,' has received approval from the U.S. Food and Drug Administration (FDA) for Phase 3 clinical trials.

This product is a biosimilar of the psoriasis treatment 'Stelara' (active ingredient ustekinumab), developed by the multinational pharmaceutical company Janssen. Stelara is a biopharmaceutical used for inflammatory diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Dong-A Socio Holdings has been jointly developing DMB-3115 with Meiji Seika Pharma since 2013. In July of last year, to improve business efficiency, the rights for development and commercialization were transferred to Dong-A ST. Currently, Dong-A ST and Meiji Seika Pharma are jointly developing the product.

This product completed preclinical trials in Europe and South Korea in 2018 and has been conducting Phase 1 clinical trials in Europe since November 2019.

The current global Phase 3 clinical trial targets patients with moderate to severe chronic plaque psoriasis. Clinical samples produced by DM Bio, a subsidiary of Dong-A Socio Holdings, will be used to compare the efficacy and safety of subcutaneous injections of DMB-3115 and Stelara.

Dong-A ST plans to start the U.S. Phase 3 clinical trial of DMB-3115 within the first quarter of this year and sequentially apply for Phase 3 trials in nine European countries. After completing the clinical trials, the product is planned to be launched in the U.S. (September 2023) and Europe (July 2024), coinciding with the expiration of Stelara's substance patent.