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Protagonist Begins Clinical Trial of Novel Oral Targeted Therapy for IBD
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Protagonist Therapeutics today announced the initiation of a phase 1 clinical trial of PTG-100, an orally stable alpha-4-beta-7 integrin-specific peptide antagonist in development for inflammatory bowel disease, according to a press release.
“IBD is a chronic inflammatory disease of the gastrointestinal tract where there is significant need for improved targeted therapies,” Richard Shames, MD, chief medical officer at Protagonist, said in the press release. “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 randomized, double-blind, placebo-controlled, dose-escalation trial involves 70 healthy participants in Australia. Single-ascending doses of PTG-100 will be given to 40 volunteers in the first part of the study, and the agent will be given to 30 additional volunteers over two weeks in the second part. Safety and tolerability of the investigational agent will serve as primary endpoints, while the maximum tolerated dose and pharmacokinetics and pharmacodynamics will serve as secondary endpoints, according to the press release.
“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,” Dinesh Patel, PhD, president and CEO of Protagonist, said in the press release. “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.”
Disclosures: Shames and Patel are employees of Protagonist.