The first patient has been dosed in Protagonist Therapeutics’ Phase 2 clinical trial of PTG-200 for the treatment of moderate to severe Crohn’s disease, the company announced.
Still recruiting at 99 sites around the world, the randomized, placebo-controlled PRISM trial (NCT04102111) is evaluating the efficacy of twice-daily dosing of PTG-200 in 90 patients with moderate to severe Crohn’s disease.
Protagonist Therapeutics and Janssen Research & Development are working together to develop PTG-200 through the completion of the proof-of concept-study.
“We are pleased to be progressing PTG-200 in collaboration with Janssen in a Phase 2 study in patients with Crohn’s disease,” Dinesh V. Patel, PhD, Protagonist’s president and CEO, said in a press release.
PTG-200 is an interleukin-23 (IL-23) receptor (IL-23R) inhibitor, designed to block the IL-23 pathway, helping fight inflammation in patients with inflammatory bowel disease (IBD). IL-23 is an inflammatory compound called a cytokine that is secreted by immune cells and known to cause inflammation, particularly in the context of IBD.
There are several available antibody treatments that target the IL-23 pathway in patients with IBD.
PTG-200 is being developed as an alternative to these current injectable treatments as a safer and more tolerable therapy. Additionally, as an oral treatment, patients may be more likely to stick to a treatment plan with PTG-200 than therapies given through injection.
Of particular importance, PTG-200 is restricted to the gut, which means there is a lower chance of any off-target effects in other tissues of the body.
“We believe this gut-restricted oral therapy may offer meaningful advantages over injectable therapeutics currently available for Crohn’s disease and other inflammatory bowel diseases. We look forward to results from this study in 2021,” Patel said.
The primary objective of the study is changes in the Crohn’s Disease Activity Index score, a measure of disease severity, at 12 weeks compared with the start of the study.
Researchers will also evaluate changes from the study’s start concerning the simple endoscopic score for Crohn’s disease, clinical response and remission, endoscopic response and remission, and patient-reported outcome (PRO)-2 remission.
Data from a randomized, double blind, placebo-controlled Phase 1 trial had previously shown that PTG-200 was safe and well tolerated in healthy volunteers.
As per the contract between the two companies, Janssen will take over additional development and commercialization of the investigational therapy after Phase 2 development.
Moreover, Protagonist may be qualified to earn more than $1 billion in research, development, regulatory, and sales target payments associated with PTG-200 and similar compounds.