Shots:

• The P-I study involves assessing pharmacokinetics- safety- and tolerability of DMB-3115 with its reference products (US- and EU-marketed products) in 296 healthy volunteers at a single site in the EU
• DMB-3115 showed bioequivalence to the reference and was well tolerated. The reported AEs corresponded with the known safety profile of ustekinumab with no new unexpected AEs
• The company has initiated P-III multi-regional clinical trials assessing DMB-3115 and reference products (45mg or 90mg- SC- respectively) in patients with plaque psoriasis- with the target number of patients being 590 and has been initiated in the EU & the US

Ref: Business Wire | Image: Business Wire