Protagonist Therapeutics Announces First Subject Dosed in Phase 1 Study of Oral IL-23 Receptor Antagonist PN-235 (JNJ-77242113)
"PN-235 is the first second-generation, oral, IL-23 receptor antagonist candidate as part of our research collaboration with Janssen to enter clinical development and was discovered through the application of the Protagonist peptide technology platform," commented
The PN-235 Phase 1 study will be conducted in three parts: a single ascending dose, a multiple ascending dose, and a randomized, crossover solid dose comparison part. The primary endpoint is safety as measured by number and severity of adverse events. Secondary outcomes include pharmacokinetics measurements of peak concentration (Cmax) of and area under the curve (AUC). Information on the study is available at https://clinicaltrials.gov/ct2/show/NCT04621630.
Protagonist and Janssen have established a co-development and commercialization agreement for IL-23 receptor targeted therapeutics with applications in various disease areas. According to the terms of the agreement, Janssen will be responsible for further development and commercialization activities of candidates beyond Phase 2 development. Protagonist is eligible to receive research, development, regulatory and sales milestone payments and has an option to co-detail products in the U.S. market.
Protagonist is headquartered in
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