Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) on Sunday announced new data from its clinical development program evaluating once-daily, oral investigational palsonify (paltusotine) in acromegaly.
Acromegaly is a rare condition in adults that causes some bones, organs and other tissues to grow bigger.
The data will be presented at the Endocrine Society’s Annual Meeting, ENDO 2025.
Also Read: JP Morgan Survey: 90% Of Endocrinologists Are Aware Of Crinetics’ Atumelnant Data
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 period.
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 also remained stable at week 96.
PATHFNDR-2 OLE Study
The interim analysis includes efficacy data from 88 patients through week 84 (corresponding to 60 weeks in the OLE), with safety data reported for all 114 enrolled.
Patients who had received a placebo during the RC phase experienced sustained reductions in IGF-1, with a mean change from baseline of –0.81 × ULN at week 84 (n=39).
Direct-to-OLE participants (n=9) showed similar reductions (–0.75 × ULN), while those who had been treated with palsonify during the RC phase (n=40) maintained control (mean change –0.01 × ULN).
Growth hormone, symptom scores, and pituitary tumor size were durably controlled over the study period.
In both trials, palsonify was well-tolerated.
A pooled analysis of symptom scores from PATHFNDR-1 and PATHFNDR-2 showed that greater proportions of patients treated with palsonify experienced less acromegaly symptom burden compared to placebo, regardless of the magnitude of the symptom effect, treatment history or state of biochemical disease control.
In an analysis of PATHFNDR-1 data, biochemically controlled patients switching from injected SRLs to palsonify saw a significant drop in day-to-day symptom exacerbations, from over 30% of days on SRLs to just 6.2% during stable palsonify dosing.
CRNX Price Action: Crinetics Pharmaceuticals stock is up 3.07% at $32.91 at publication on Monday.
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