Crinetics Pharmaceuticals has revealed new data from its clinical development programme for Palsonify, an investigational oral treatment for acromegaly.
The trial focuses on the long-term clinical profile of the oral therapy using data from the Phase III PATHFNDR-1 and PATHFNDR-2 trials’ open-label extension (OLE) trials.
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In the PATHFNDR-1 trial, adult patients with acromegaly biochemically controlled on injectable somatostatin receptor ligands (SRLs) were enrolled.
After a 36-week randomised, placebo-controlled period, 53 of 58 subjects entered the ongoing single-arm OLE.
Data from the first 96 weeks of the trial’s total participation time were included in an interim analysis.
At the 96-week mark, insulin-like growth factor 1 (IGF-1) levels stayed stable in subjects who changed to Palsonify, indicating sustained biochemical control.
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By GlobalDataGrowth hormone levels and symptom control, assessed according to the Acromegaly Symptom Diary (ASD), also remained consistent, with the therapy being well tolerated.
The placebo-controlled, double-blind, randomised PATHFNDR-2 trial similarly showed positive outcomes for patients with biochemically uncontrolled acromegaly.
After a 24-week randomised controlled period, 103 of 106 subjects who completed the trial entered into the ongoing OLE, alongside 11 additional subjects eligible for the randomised controlled phase but who enrolled directly into the OLE following the completion of the randomised controlled enrolment.
Efficacy data from 88 subjects through week 84 were included in this interim analysis, with safety data reported for all 114 subjects enrolled.
At the 84-week mark, patients who were given a placebo during the randomised controlled period saw significant decreases in IGF-1 levels.
The Palsonify-treated subjects maintained control, with stable growth hormone levels, symptom scores, and pituitary tumour sizes. The safety profile of the therapy indicated that it remained well tolerated.
A pooled analysis of ASD scores from both trials indicated that subjects treated with the therapy experienced a lower symptom burden than those receiving a placebo.
Crinetics Pharmaceuticals CEO and founder Scott Struthers said: “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.”
