This contribution to the literature is the first published retinoic acid-related orphan receptor gamma (RORγ) inhibitor population PK or PKPD model based on clinical data.
A collaborative team at Boehringer Ingelheim and Pharmetheus developed PK and PKPD models to predict outcomes for multiple BI 730357 dosage regimens, targeting RORγ, in patients with moderate-to-severe plaque psoriasis.
“The resulting bounded integer model with improved numerical stability successfully characterized the BI 730357 effect on the observed psoriasis area and severity index.” observed Qing Xi, who continued: “Simulation using replicates of a mimicked Phase III study design enabled robust outcome predictions, which ultimately contributed to model-informed drug development decisions.”
Title of the publication: Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357
Find the publication published in CPT Pharmacometrics Systems Pharmacology:
Boehringer Ingelheim affiliates: Julia Korell, Mary Flack, Benjamin Weber