PTG-200, being developed by Protagonist Therapeutics in collaboration with Janssen Biotech for the treatment of moderate and severe Crohn’s disease, was found safe and well-tolerated in healthy volunteers, according to top-line results of a Phase 1 clinical trial.
PTG-200 is a first-in-class peptide that works by blocking the function of interleukin-23 receptor (IL-23R), a cell receptor involved in the immune and inflammatory response associated with inflammatory bowel diseases (IBD).
Unlike other therapies on the market that target IL-23R and are delivered by injection, PTG-200 can be taken orally, making it much more convenient, safer and well-tolerated by patients.
The findings from the randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study, which has just been completed in Australia, showed that PTG-200 was well-tolerated in 80 healthy volunteers, without serious adverse effects or toxicity.
The therapy’s effects and chemical properties were in agreement with the characteristics of the peptide that was specifically developed to remain within the patients’ gastrointestinal (GI) tract.
“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,” Dinesh V. Patel, PhD, Protagonist Therapeutics’ president and CEO, said in a press release.
“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 [investigational new drug] filing with our collaboration partner Janssen Biotech in the coming months,” Patel added.
Besides PTG-200, the company is currently developing PTG-100, an oral peptide that blocks alpha-4-beta-7 integrin — another cell receptor linked to GI tract inflammation — for the treatment of moderate and severe ulcerative colitis.
“We believe PTG-100 and PTG-200 have the potential to transform the existing IBD treatment paradigm because they offer significant advantages over injectable antibody drugs. Furthermore, there is the potential to use PTG-100 and PTG-200 as monotherapies as well as in combination with each other or with other targeted therapies,” the company says on its website.