Autonomous Cortisol Secretion
A prevalent, yet serious disorder of cortisol excess with significant morbidity and increased risk of mortality.
What is autonomous cortisol secretion?
Autonomous cortisol secretion (ACS) is caused by the overproduction of cortisol from a tumor of the adrenal gland. It is a somewhat milder form of hypercortisolism than Cushing’s. As patients with ACS lack the outward clinical features of Cushing’s and their symptoms present as common, chronic conditions, it is rarely diagnosed.
ACS is currently only discovered when the tumor shows up on a scan for an unrelated health condition and the patient subsequently receives an adequate endocrine workup. As this infrequently occurs, most patients with ACS are dangerously exposed to excess cortisol for long periods, leading them to face major health complications, significant healthcare costs, and increased risk of early death.
The signs and symptoms of ACS vary across a wide range of mental and physical effects – including diabetes, hypertension, bone fractures, and weight gain, as well as mood, cognition, and sleep disorders.
Autonomous cortisol secretion may effect up to 3% of the adult population in the U.S. and EU.¹
The need.
As ACS usually goes unrecognized, it is most often treated symptomatically for its various sequelae. However, current therapies do not address the root of the problem, thereby potentially relieving multiple symptoms at once, and can carry their own unwanted side effects.
Once diagnosed, the only recommended treatment for addressing the underlying condition is surgical removal of the tumor. This approach carries its own significant health risks.
Patients with ACS need a safer option than surgery.
Our product candidate.
We are currently developing what could be the first approved therapy for patients with ACS: SPI-62. SPI-62 works to target a source of cortisol causing toxicity, rather than just addressing some of its numerous symptoms. We believe it could transform the health and quality of life for this large and underserved patient population.
Oral, once-a-day administration, no complex monitoring necessary.
SPI-62 has demonstrated the ability to lower intracellular cortisol levels in vital organs, with a favorable safety and tolerability profile in five clinical trials. These studies also showed improvement in glucose, HbA1c, cholesterol, and triglycerides.
¹ Bancos I, Alahdab F, Crowley RK, Chortis V, Delivanis DA, Erickson D, Natt N, Terzolo M, Arlt W & Young Jr WF et al.THERAPY OF ENDOCRINE DISEASE: Improvement of cardiovascular risk factors after adrenalectomy in patients with adrenal tumors and subclinical Cushing’s syndrome: a systematic review and meta-analysis. European Journal of Endocrinology 2016175 R283–R295.