US-based biotechnology company Corcept Therapeutics has reported positive long-term outcomes from its Phase III study of relacorilant, a treatment for individuals with endogenous hypercortisolism, also known as Cushing’s syndrome.
In the trial, the therapy showed sustained cardiometabolic improvements and high tolerance over a treatment period of up to six years.
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The open-label extension study enrolled 116 subjects who had completed either the GRACE or GRADIENT studies or Phase II clinical trial in hypercortisolism.
These subjects continued to show improvements in blood pressure and maintained their response in other cardiometabolic measures, such as body weight and glycaemic control.
After 24 months, subjects showed statistically significant reductions in mean systolic and diastolic blood pressure in comparison to their initial measurements at the start of the extension study.
This was particularly notable in subjects who had been switched to placebo during the GRACE study and then resumed relacorilant in the extension study, as they not only reversed the deterioration seen on placebo but achieved additional improvements.
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By GlobalDataA 24-hour ambulatory blood pressure monitoring was used to ensure precision.
Corcept’s selective cortisol modulator, relacorilant, is designed to target the glucocorticoid receptor without affecting other hormone receptors.
Corcept Therapeutics chief development officer Bill Guyer said: “The positive results from the long-term extension study of relacorilant are consistent with findings from our GRACE, GRADIENT and Phase II studies.
“These data will support relacorilant’s new drug application (NDA), which we plan to submit this month.
“Relacorilant’s strong efficacy and safety profile positions the medication to become a new standard of care in treating patients with hypercortisolism.”
In addition to Cushing’s syndrome, relacorilant is being investigated for its potential use in treating various cancers, including ovarian, adrenal and prostate cancer.
Corcept holds proprietary rights to the therapy, which is protected by several patents and has received orphan drug designation in both the US and the European Union.
