Core Insights - Crinetics Pharmaceuticals has initiated the pivotal Phase 3 CAREFNDR trial to evaluate the efficacy and safety of paltusotine for treating carcinoid syndrome associated with neuroendocrine tumors, building on positive Phase 2 results [1][2][3] Company Overview - Crinetics Pharmaceuticals is focused on developing transformative therapies for endocrine diseases and related tumors, with a core expertise in targeting G-protein coupled receptors [7][8] - The company’s lead product, paltusotine, is the first once-daily oral treatment approved for adults with acromegaly who have had an inadequate response to surgery [8] Clinical Trial Details - The CAREFNDR trial will enroll 141 adults with carcinoid syndrome, randomizing participants in a 2:1 ratio to receive either paltusotine 80 mg or a matching placebo [2] - The primary endpoint of the trial is to measure the change in flushing episodes per day from baseline to Week 12, with bowel movement frequency as a key secondary endpoint [2] - Following the 16-week randomized period, the trial includes a 104-week open-label extension to evaluate long-term efficacy and safety [2] Product Information - Paltusotine is a selectively-targeted somatostatin receptor type 2 (SST2) nonpeptide currently in Phase 3 development for carcinoid syndrome, showing rapid and sustained reductions in symptoms during Phase 2 trials [5][6] - Approximately 20% of patients with neuroendocrine tumors experience carcinoid syndrome, characterized by symptoms such as diarrhea and flushing [6] Future Development - Crinetics is also exploring additional treatment options for neuroendocrine tumors through CRN09682, an investigational anti-tumor candidate that has received Investigational New Drug clearance [3]