Crinetics to Present New Long-Term Data Demonstrating Durable Control of Once-Daily, Oral PALSONIFY (Paltusotine) in Acromegaly at ENDO 2025

Data show that PALSONIFY was well tolerated and IGF-1 levels remained stably controlled during long-term open label extensions of PATHFNDR-1 and PATHFNDR-2 studies

Additional PALSONIFY presentations demonstrate reductions in patient-reported symptom burden, including both symptom severity and rates of symptom flares

SAN DIEGO, July 13, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced new data from its clinical development program evaluating once-daily, oral investigational PALSONIFY^TM (paltusotine) in acromegaly will be presented in several oral and poster presentations at the Endocrine Society’s Annual Meeting, ENDO 2025. Notably, open-label extension (OLE) data from both the pivotal PATHFNDR-1 and PATHFNDR-2 trials will be featured in two presentations, showing the long-term clinical profile of PALSONIFY in people with acromegaly.

“With once-daily, oral PALSONIFY’s PDUFA date quickly approaching, we’re excited to see a growing body of data that continues to underscore its potential as the next generation of care for people living with acromegaly,” said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. “Building on the remarkable Phase 3 trial results from the PATHFNDR studies that we’ve presented at ENDO previously, the new long-term data we’re showcasing this year provide further evidence of PALSONIFY’s ability to deliver durable IGF-1 control, sustained improvements in patient symptom burden, and a consistent safety profile.”

PATHFNDR-1 Open-Label Extension (OLE) Study
The PATHFNDR-1 Phase 3 trial enrolled adults with acromegaly who were biochemically controlled on monthly injectable somatostatin receptor ligands (SRLs). Following a 36-week randomized, placebo-controlled period, 53 of 58 participants (91%) entered the ongoing single-arm open-label extension. An interim analysis includes data through Week 96 of total study participation (60 weeks in the OLE).

• In patients who transitioned from injected SRLs to once-daily oral PALSONIFY, mean insulin-like growth factor 1 (IGF-1) levels remained stable with IGF-1 (mean ± SE) of 0.93 ± 0.22 at OLE baseline and 0.81 ± 0.21 times the upper limit of normal (ULN) at Week 96, demonstrating durable biochemical control over this time span.
• Growth hormone (GH) levels were also stable, with mean values of 1.0 ± 1.0 ng/mL at baseline and 1.1 ± 1.2 ng/mL at Week 96.
• Symptom control, as measured by the Acromegaly Symptom Diary (ASD)—a seven-item daily patient-reported outcome assessing core acromegaly symptoms such as headache, joint pain, sweating, fatigue, and soft tissue swelling—also remained stable at Week 96.
• PALSONIFY was generally well tolerated.

These results will be included in an oral presentation titled “Disease Control in Patients With Acromegaly Switching From Injected Somatostatin Receptor Ligands to Once-Daily Oral Paltusotine: Interim Results of the PATHFNDR-1 Open-Label Extension,” taking place July 13 from 2:45-3:00 PM PT.

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