- Protagonist Therapeutics (NASDAQ:PTGX) initiates a Phase 2b induction study assessing lead product candidate PTG-100 in patients with moderately to severely active ulcerative colitis (UC). The 240-subject four-arm study will evaluate the safety and efficacy of three dosages (150 mg, 300 mg, 900 mg) of PTG-100 for 12 weeks followed by a four-week observation period.
- An interim futility analysis will be performed in H2. If futility criteria are not met, one or two optimal doses will be selected for continued randomization of the remaining patients.
- The primary endpoint is the proportion of patients achieving clinical remission as measured by a scale called Mayo Score compared to placebo. According to ClinicalTrials.gov, the estimated study completion date is May 2018.
- PTG-100 is an oral alpha4beta7 integrin antagonist. Alpha4beta7 binds to a protein called MAdCAM-1 that resides in the GI vasculature that acts as a homing receptor for white blood cells called lymphocytes. Blocking the receptors lowers the levels of lymphocytes which lessens inflammation.