Sparrow Pharmaceuticals has dosed the first subject in the Phase II ACSpire clinical trial of SPI-62 to treat autonomous cortisol secretion (ACS).
ACS is a condition caused by excessive cortisol production from a benign tumour of the adrenal gland.
The long-term, open-label trial is designed to assess the safety, efficacy, and pharmacological effects of SPI-62 in subjects with hypercortisolism linked to a benign adrenal tumour.
In addition, the impact of SPI-62 on hypercortisolism morbidities, including diabetes or impaired glucose tolerance, hyperlipidemia, hypertension, and osteopenia, will also be evaluated.
The trial is enrolling up to 30 subjects at study centres in the US, with sites in Romania, France, and the UK to be added in the future.
SPI-62 is a selective inhibitor of HSD-1.
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ACSpire will complement the Phase II RESCUE study that is currently underway to treat ACTH-dependent Cushing’s syndrome.
Sparrow Pharmaceuticals chief medical officer Frank Czerwiec said: “ACS is a dangerous condition, with high morbidity and risk of death, with patients often having unexplained metabolic disease, cardiovascular disease, or osteopenia, and experiencing a 35% higher rate of mortality over a five-year span.
“However, most patients don’t even know they have ACS and are only diagnosed after an appropriate endocrine workup following the discovery of an adrenal tumour on a CT or MRI scan for unrelated reasons.
“SPI-62 could represent the first treatment to be approved for this large yet underappreciated and underserved patient population.”