Milpitas, CA - Protagonist Therapeutics, Inc., a company developing novel, orally-stable peptide therapeutics for gastrointestinal (GI) diseases, today announced that the company has initiated treatment of subjects with its lead drug candidate, PTG-100, in a Phase 1 clinical study. Protagonist is developing PTG-100, an orally-stable alpha-4-beta-7 integrin-specific peptide antagonist, as a potential treatment for patients with inflammatory bowel disease (IBD).
“IBD is a chronic inflammatory disease of the gastro-intestinal tract where there is significant need for improved targeted therapies,” said Richard Shames, M.D., Chief Medical Officer at Protagonist. ”PTG-100 is the only oral alpha-4-beta-7 specific antagonist currently in development, a target that is clinically validated for IBD by the approval of injectable antibody drugs.”
“The initiation of the first human study of PTG-100 is an important milestone for Protagonist, marking our evolution from a research-focused company to one engaged in the clinical development of its own products,” said Dinesh Patel, Ph.D., Protagonist President and Chief Executive Officer. “PTG-100 is the first of several orally stable peptides in the Protagonist pipeline. We look forward to applying the lessons we learn from this compound’s early development to our other programs.”
The Phase 1 study, which is being conducted in Australia, is a randomized, double-blind, placebo-controlled, dose-escalation trial in 70 normal healthy volunteers. The first part of the study consists of single-ascending doses of PTG-100 in 40 volunteers. The second part of the study will involve the administration of PTG-100 over 14 consecutive days in 30 additional volunteers. Primary endpoints for the study are safety and tolerability of PTG-100. Secondary endpoints are the identification of the maximally tolerated dose and evaluation of pharmacokinetic and pharmacodynamic parameters.
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