US-based clinical-stage biopharmaceutical company Protagonist Therapeutics has initiated its Phase IIb clinical trial of PTG-100 to treat ulcerative colitis.
PTG-100 is an orally administered peptide developed to target Alpha4beta7 integrin.
The Alpha4beta7 integrin is considered responsible for targeting inflammatory bowel disease as it binds with MAdCAM-1, a cell membrane protein that is mostly expressed in the gastrointestinal (GI) vasculature.
The Phase IIb study is being conducted as a randomised, double-blind, placebo-controlled, adaptive design study intending to test the safety, tolerability and efficacy of PTG-100 while examining 240 adult ulcerative colitis patients with moderate-to-severe active disease.
The patients will be randomised to receive one among 150mg / 300mg / 900mg dosages of PTG-100 or placebo on a once-daily basis for 12 weeks and will then be followed up for safety for four weeks.
The primary efficacy of the study is to achieve clinical remission from rectal bleeding and stool frequency, which will be determined on the basis of endoscopic subscores of the Mayo Score.
The study's secondary endpoints are to determine additional clinical and safety assessments, as well as pharmacokinetic, pharmacodynamic and other biomarker measurements of disease activity.
Protagonist Therapeutics president and CEO Dinesh Patel said: "PTG-100 is the most advanced asset to have emerged from our proprietary oral peptide technology platform that enables de novo discovery and optimisation of novel peptides for protein:protein interaction (PPI) targets.
"Since these PPI targets have typically been approached by injectable antibody drugs, our platform offers the distinct advantage of generating oral therapeutic assets against the same PPI targets utilised by approved antibody drugs.”
The company will conduct an interim futility analysis of the study in the second half of this year, based on which it will select one or two PTG-100 optimal doses to be administered to the remaining patients.
Image: Colonic biopsy displaying H&E stain in ulcerative colitis. Photo: courtesy of KGH.