- Crinetics Pharmaceuticals (CRNX, Financial) presents new long-term data for PALSONIFY™ (paltusotine) at ENDO 2025.
- PALSONIFY shows durable biochemical control and symptom reduction in acromegaly patients in Phase 3 trials.
- Data indicates significant improvement for patients switching from injectable treatments to oral PALSONIFY.
Crinetics Pharmaceuticals (CRNX) has unveiled promising long-term data for its investigational once-daily oral treatment, PALSONIFY™ (paltusotine), aimed at managing acromegaly. The findings are set to be presented at the Endocrine Society’s ENDO 2025 annual meeting.
The data, derived from the open-label extensions of two Phase 3 trials—PATHFNDR-1 and PATHFNDR-2—underscore PALSONIFY's ability to maintain stable insulin-like growth factor 1 (IGF-1) levels over extended periods. In PATHFNDR-1, patients who transitioned from injectable somatostatin receptor ligands (SRLs) to PALSONIFY showed IGF-1 levels remaining at 0.81 times the upper limit of normal by Week 96, as compared to 0.93 at baseline.
In the PATHFNDR-2 trial, aimed at patients with biochemically uncontrolled acromegaly, significant reductions in IGF-1 were observed with a mean change of -0.81 times the upper limit of normal at Week 84. These results indicate that PALSONIFY not only provides durable biochemical control but also reduces the symptom burden significantly, offering a patient-friendly oral administration alternative to traditionally injectable treatments.
Furthermore, the data show a notable decrease in the frequency of symptom flares, from over 30% when using injectable SRLs to just 6.2% with stable PALSONIFY dosing, highlighting an enhanced quality of life for patients. The drug continued to exhibit a consistent safety profile with high retention rates in both studies: 91% in PATHFNDR-1 and 97.2% in PATHFNDR-2, reinforcing its potential as a first-line therapy for patients with acromegaly.
