Protagonist Therapeutics Begins Phase 2b Trial of PTG-100 as Ulcerative Colitis Treatment

Protagonist Therapeutics Begins Phase 2b Trial of PTG-100 as Ulcerative Colitis Treatment
Protagonist Therapeutics has started a Phase 2b clinical trial to evaluate PTG-100, its lead candidate as a potential treatment for ulcerative colitis (UC). The multicenter, randomized, double-blind, placebo-controlled, parallel, adaptive two-stage trial (NCT02895100) will assess the effectiveness, safety and tolerability of PTG-100 in about 240 adults with moderate to severe UC. Researchers will randomly assign patients to one of three doses of PTG-100 -- 150, 300, 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. PTG-100 is an alpha-4-beta-7 (α4β7) integrin-specific antagonist peptide. α4β7 integrin binds with MAdCAM-1, a protein that resides mostly in the gastrointestinal vasculature, or circulatory system. Protagonist will conduct an interim futility analysis by mid-2017 to test PTG-100’s performance against the placebo. If PTG-100 has failed to outperform the placebo by then, investigators will assign one or two optimal doses of the therapy to patients chosen randomly. The primary measure of PTG-100's effectiveness will be how many patients' disease goes into clinical remission, compared with the placebo users, after 12 weeks. Clinical remission is defined as normal stool frequency without bleeding, and improvement in endoscopic scores, as measured by the Mayo Scoring System. An endoscope is an instrument used to examine body cavities. Safety will be assessed by comparing the number of adverse events among patients taking PTG-100 with the number of events among the placebo group f
Subscribe or to access all post and page content.

Leave a Comment

Your email address will not be published. Required fields are marked *