Crinetics’ paltusotine in acromegaly meets all Phase 3 study endpoints

Crinetics Pharmaceuticals announced positive topline results from PATHFNDR-2, the second of two Phase 3 studies evaluating the efficacy and safety of oral, once-daily investigational paltusotine for the treatment of acromegaly, a serious rare disease generally caused by a pituitary adenoma, a benign tumor in the pituitary that secretes growth hormone. PATHFNDR-2 was a 24-week treatment period followed by an optional open-label extension study evaluating paltusotine in 111 participants with acromegaly who were not pharmacologically treated. The study met statistical significance on the primary endpoint, based on the proportion of participants taking paltusotine (56%) who achieved an insulin-like growth factor 1 level less than or equal to 1.0 times the upper limit of normal vs. those taking placebo. All secondary endpoints also met statistical significance. In PATHFNDR-2, paltusotine was generally well-tolerated and no serious adverse events were reported in participants treated with paltusotine. The PATHFNDR Program consists of two Phase 3 double-blind, placebo-controlled studies. Crinetics believes these studies could support registration of paltusotine in the United States and Europe for all acromegaly patients who require pharmacotherapy, including untreated patients and those switching from standard of care.