In the presentation titled “The Biomarker Profile of PTG-200, an Oral Peptide Antagonist of IL-23 Receptor, Tracks with Efficacy in a Preclinical Model of IBD,” researchers will show that by inhibiting the interleukin-23 pathway with PTG-200, they saw significantly improved disease outcomes in a mouse model of IBD.
PTG-200 is a potential first-in-class oral IL-23R antagonist under development for moderate to severe Crohn’s disease, a form of inflammatory bowel disease (IBD). The drug has received investigational new drug (IND) status by the U.S. Food and Drug Administration, enabling Protagonist to begin clinical studies.
The preclinical results to be presented at the conference support translating the preclinical efficacy to clinical proof-of-studies of PTG-200 for the treatment of IBD. The company says it is the planning to begin a Phase 1 clinical trial this year.
Headquartered in Milpitas, California, Protagonist leverages its proprietary peptide technology platform to discover and develop new product candidates to treat diseases with significant unmet medical needs. The company’s pipeline also includes a compound called PTG-100, a potential first-in-class oral integrin-specific antagonist peptide product candidate being developed for the treatment of moderate to severe ulcerative colitis (UC).
PTG-100 is currently being evaluated in a Phase 2b placebo-controlled trial (NCT02895100) to study the effectiveness, safety and tolerability of the compound in about 240 adults with moderate to severe UC. Researchers will randomize patients to one of three doses of PTG-100 — 150 mg, 300 mg, or 900 mg — or to a placebo. Patients will receive doses once a day orally for 12 weeks, followed by four weeks of safety assessment.