Potential IBD Therapy PTG-200 Safe, Well-tolerated in Healthy Volunteers, Phase 1 Results Show

Potential IBD Therapy PTG-200 Safe, Well-tolerated in Healthy Volunteers, Phase 1 Results Show
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
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