Meiji Reports Results of P-I Study of DMB-3115 (proposed ustekinumab biosimilar) and Initiate P-III Study for Plaque Psoriasis

 Meiji Reports Results of P-I Study of DMB-3115 (proposed ustekinumab biosimilar) and Initiate P-III Study for Plaque Psoriasis

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

Click here to­ read full press release/ article | Ref: Business Wire | Image: Business Wire

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