Protagonist Therapeutics Announces Completion of Phase 1 Trial of PTG-200

Protagonist Therapeutics announced top-line results from the Phase 1 study of PTG-200, an oral peptide interleukin-23 receptor antagonist, in 80 normal healthy volunteers. Results of the randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study demonstrated that administration of PTG-200 was well-tolerated. No serious adverse events or dose-limiting toxicities were observed. The pharmacokinetic and pharmacodynamic parameters were consistent with the gastrointestinal-restricted design of PTG-200.
"Results from this study provide the first clinical data in support of PTG-200 and creates a path forward for its evaluation as a potential first-in-class oral IL-23 pathway based therapeutic for treatment of IBD," said Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "An oral drug targeting the IL-23 pathway would be a novel addition to the oral targeted therapy treatment landscape while building upon proven injectable therapeutic agents that work through similar validated mechanisms for IBD. We look forward to working towards a U.S. IND filing with our collaboration partner Janssen Biotech in the coming months."

PTG-200 is an oral peptide interleukin-23 receptor (IL-23R) antagonist being co-developed with Janssen Biotech, Inc., initially for the treatment of patients with Crohn's disease. PTG-200 is designed to offer advantages over 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.

A Phase 1 randomized, double-blind, placebo-controlled, single- and multiple-dose escalation trial in eighty healthy volunteers has been completed at a single site in Australia. The study was conducted in two parts: single-ascending doses and multiple ascending doses of PTG-200.

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