Protagonist Therapeutics Announces First Patient Dosed in a Phase 2 Study of Oral IL-23 Receptor Antagonist PTG-200 (JNJ-67864238) in the Treatment of Crohn's Disease
"We are pleased to be progressing PTG-200 in collaboration with Janssen in a Phase 2 study in patients with Crohn's disease," commented
The global, randomized, double blind, placebo-controlled, Phase 2 study is evaluating the efficacy of oral administration of PTG-200 in 90 patients with moderate to severe Crohn's disease. The study will assess the effect of twice-daily dosing of PTG-200 on change from baseline in Crohn's Disease Activity Index (CDAI) score at week 12 as the primary endpoint. The study will also assess change from baseline in simple endoscopic score for Crohn's disease (SES-CD), rates of clinical response and remission, endoscopic response and remission, and patient-reported outcome (PRO)-2 remission. Additional information on the PTG-200 Crohn's disease study is available at https://clinicaltrials.gov/ct2/show/NCT04102111.
According to the terms of the development agreement between
About PTG-200 (JNJ-67864238)
PTG-200 is an oral peptide interleukin-23 receptor (IL-23R) antagonist being co-developed with Janssen, for the treatment of inflammatory bowel disease and is initially in development for the treatment of patients with Crohn's disease. PTG-200 is designed to offer choices to patients in addition to injectable antibody therapeutics that target the IL-23 pathway, including the potential for improved safety and tolerability and better compliance compared to therapeutics administered by injection.
Results from a Phase 1 randomized, double blind, placebo-controlled, single- and multiple-dose escalation trial in healthy volunteers demonstrated that PTG-200 was well tolerated, with pharmacokinetic measures consistent with the gut-restricted design of PTG-200.
Protagonist is headquartered in
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