Protagonist Therapeutics Initiates Phase 2b Study of Oral Drug Candidate PTG-100 in Ulcerative Colitis
January 17, 2017 at 08:00 am
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Protagonist Therapeutics, Inc. 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. 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. The primary efficacy endpoint of the study is clinical remission (as defined by rectal bleeding, stool frequency, and endoscopic subscores of the Mayo Score). Secondary endpoints include additional clinical and safety assessments, as well as pharmacokinetic, pharmacodynamic and other biomarker measurements of disease activity. PTG-100 is a potential first-in-class product candidate that is being developed initially for the potential treatment of moderate-to-severe active ulcerative colitis. Alpha4beta7 integrin is considered to be one of the most gastrointestinal-specific biological targets for inflammatory bowel disease due to its binding to MAdCAM-1, a cell membrane protein that resides mostly in the gastrointestinal (GI) vasculature.
Protagonist Therapeutics, Inc. is a biopharmaceutical company. The Company uses its peptide-based chemical entities rusfertide and JNJ-2113 in different stages of development, all derived from its proprietary discovery technology platform. The Companyâs clinical programs fall into two categories of diseases: hematology and blood disorders, and inflammatory and immunomodulatory diseases. Its lead clinical asset, rusfertide (PTG-300), is an injectable hepcidin mimetic in development for the potential treatment of polycythemia vera (PV) and other blood disorders. The Companyâs Interleukin-23 receptor (IL-23R) antagonist compound JNJ-2113 is an orally delivered investigational drug that is designed to block biological pathways targeted by marketed injectable antibody drugs. Its PN-943 is a wholly owned investigational orally delivered gut-restricted alpha 4 beta 7 (α4β7) specific integrin antagonist for inflammatory bowel disease (IBD).