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Positive phase I results for Meiji’s ustekinumab biosimilar

Biosimilars/Research | Posted 04/06/2021 0 Post your comment

Japan-based Meiji Seika Pharma (Meiji) announced on 21 May 2021 positive phase I results for its candidate ustekinumab biosimilar, DMB-3115.

Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL 12 and IL 23 which help activate certain T-cells. It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors. It is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis.

The phase I study is a randomized double-blind, three-arm, single-dose study to compare the 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 Europe.

Meiji reports that the results of the study demonstrate ‘bioequivalence of DMB-3115 compared to reference products’ … ‘in terms of several pharmacokinetic parameters’. They add that ‘a single subcutaneous injection of DMB[-]3115 in healthy volunteers was well tolerated’ and that ‘the reported adverse events corresponded with the known safety profile of ustekinumab’. According to Meiji, there were also ‘no new unexpected adverse events’.

Meiji also announced the initiation of a phase III multi-regional clinical trial (NCT04785326: Opportuniti) in patients with plaque psoriasis. The phase III trial will study the efficacy, safety and immunogenicity of subcutaneous DMB-3115 versus originator ustekinumab (Stelara) in patients with moderate to severe chronic plaque psoriasis. The trial is currently recruiting. It plans to enrol 590 patients and is expected to be completed in November 2022.

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Source: ClinicalTrials.gov, Meiji Seika Pharma