Source: Protagonist Therapeutics, Inc. & reported by http://www.prnewswire.com/
MILPITAS, Calif., Jan. 17, 2017 /PRNewswire/ - Protagonist Therapeutics, Inc. (NASDAQ: PTGX) today announced that it has initiated a global Phase 2b induction study in ulcerative colitis with PTG-100, an oral peptide that targets alpha4beta7 integrin. The aim of this randomized, double-blind, placebo-controlled, adaptive design study is to evaluate the safety/tolerability and efficacy of PTG-100 in approximately 240 adult ulcerative colitis patients with moderate to severe active disease.
"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," said Richard Shames, M.D., Chief Medical Officer at Protagonist. "We expect to complete the study and report top-line data in second half of 2018."
Patients will be randomized to one of four dose arms (150mg/300mg/900mg PTG-100 or placebo) for 12 weeks of once-daily oral dosing, followed by four weeks of safety follow-up. An interim futility analysis is expected to be performed in the second half of 2017, and if futility criteria are not met, one or two PTG-100 optimal doses will be selected for continued randomization of the remaining patients.
Read more: http://www.prnewswire.com/news-releases/protagonist-therapeutics-initiates-phase-2b-study-of-oral-drug-candidate-ptg-100-in-ulcerative-colitis-300391589.html