Crinetics reports two-year PALSONIFY acromegaly treatment data
Crinetics Pharmaceuticals Inc. (NASDAQ: CRNX) presented long-term clinical data for its acromegaly treatment PALSONIFY at the Endocrine Society's Annual Meeting on June 14. The data covered up to two years of treatment from open-label extension studies of the PATHFNDR-1 and PATHFNDR-2 trials.
In the PATHFNDR-1 extension study, 53 patients who had switched from monthly injectable treatments maintained stable IGF-1 levels over 96 weeks. Baseline IGF-1 levels of 0.91 times the upper limit of normal remained at 0.81 times the upper limit at 96 weeks. All patients showed stable pituitary tumor volumes at 48 weeks.
The PATHFNDR-2 extension study included 114 patients with previously uncontrolled acromegaly. Their IGF-1 levels decreased from a baseline of 1.64 times the upper limit of normal to 0.96 times the upper limit at 72 weeks. Seven of 83 patients with available MRI scans showed tumor volume reductions greater than 20% at week 24, while the remaining 76 patients had stable tumor volumes.
In the combined extension studies with 167 patients, the most common adverse events were diarrhea (15.6%), arthralgia (11.4%), headache (11.4%), and urinary tract infection (10.2%). Four patients discontinued treatment due to adverse events.
The company also presented data from its ACROBAT study showing that combining PALSONIFY with cabergoline improved biochemical control in acromegaly patients followed for up to four years.
PALSONIFY received FDA approval in late 2025 as the first once-daily oral treatment for adults with acromegaly who had inadequate surgical response or cannot undergo surgery.
