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Protagonist begins phase 2b study of oral drug candidate for ulcerative colitis
Protagonist Therapeutics has begun a global phase 2b induction study of its investigational oral alpha4beta7 integrin antagonist in ulcerative colitis.
“We are very pleased to advance our oral, alpha4beta7 integrin-specific antagonist peptide candidate, PTG-100, into this clinical proof-of-concept and dose optimization study,” Richard Shames, MD, chief medical officer at Protagonist, said in a press release. “We expect to complete the study and report top-line data in second half of 2018.”
Alpha4beta7 integrin is thought to be among the most GI-specific biological targets for inflammatory bowel disease based on its binding to MAdCAM-1, a cell membrane protein found primarily in the GI vasculature, according to the press release.
To assess the safety, tolerability and efficacy of PTG-100, investigators from about 100 international sites are conducting this randomized, double blind, placebo-controlled adaptive design study in about 240 adults with moderate-to-severe active ulcerative colitis.
Patients will be randomly assigned to receive 150 mg, 300 mg, or 900 mg of PTG-100 or placebo once daily for 12 weeks, and will be followed for an additional 4 weeks to evaluate safety.
Clinical remission will serve as the primary endpoint, and additional clinical and safety assessments, pharmacokinetic, pharmacodynamic and other biomarker measurements of disease activity will serve as secondary endpoints.
Optimal doses will be chosen for continued randomization of remaining patients at an interim futility analysis in the second half of this year, according to the press release.
“PTG-100 is the most advanced asset to have emerged from our proprietary oral peptide technology platform that enables de novo discovery and optimization of novel peptides for protein:protein interaction (PPI) targets,” Dinesh Patel, PhD, president and CEO of Protagonist, said in the press release. “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 utilized by approved antibody drugs. We look forward to advancing PTG-100 to clinical proof-of-concept in patients with ulcerative colitis and applying our technology platform to discovering other novel peptidic assets to address unmet medical needs.”
The company is also developing PTG-200, an oral interleukin-23 receptor antagonist, for moderate-to-severe Crohn’s disease, which is being evaluated in IND-enabling studies, according to the press release.
Disclosures: Patel and Shames are employed by Protagonist.