Meiji Seika Pharma and Dong-A Socio Holdings Initiate Phase I Clinical Trial of DMB-3115, a Ustekinumab Biosimilar Candidate
[caption id="attachment_9277" align="aligncenter" width="1079"] Press Release[/caption]
Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan, President and Representative
Director: Daikichiro Kobayashi, ?Meiji?) and Dong-A Socio Holdings Co., Ltd.
(Headquarters: Seoul, Korea, CEO: Jong Hyun Han, ?Dong-A?) today announced the
initiation of a Phase I clinical trial of DMB-3115.
The Phase I clinical trial is a randomized double-blind, three-arm, single-dose study to
compare pharmacokinetics, safety and tolerability of DMB-3115 with its reference products
(US- and EU-marketed products under the name of Stelara?) in healthy volunteers at a
single site in Europe. The dosing for subjects in the study was started on 13 December.
Meiji and Dong-A are developing DMB-3115 as a biosimilar candidate to ustekinumab, a
recombinant immunoglobulin G1kappa monoclonal antibody targeting interleukin (IL)-12
and IL-23. The reference product has been approved in many regions for the treatment of
patients with several inflammatory diseases such as plaque psoriasis, psoriatic arthritis,
Crohn?s disease and ulcerative colitis.
The investigational product of DMB-3115 for the Phase I study was manufactured by DM
Bio Limited (Headquarters: Incheon, Korea, CEO: Byoung Jo Min), established as a joint
venture company in Incheon Free Economic Zone, under the strategic collaboration
partnership agreement on biosimilars between Meiji and Dong-A signed in September
2011.