SPI-62
A highly potent and selective, small molecule HSD-1 inhibitor.
What is SPI-62?
A new way to control cortisol levels and mitigate their negative effects.
SPI-62 is our proprietary, oral small molecule, new chemical entity, HSD-1 inhibitor, designed to reduce intracellular cortisol levels and mitigate its numerous adverse effects. We are currently developing SPI-62 for conditions directly caused by an overproduction of cortisol in the body.
SPI-62 may represent the first new mechanism of action in decades approved for patients suffering from endogenous Cushing’s syndrome (CS) and Autonomous Cortisol Secretion (ACS).
How it Works
Targeting intracellular cortisol.
HSD-1 is a major source of intracellular cortisol in key tissues where excess cortisol causes morbidity, such as the liver, adipose (fat), bone, and brain.
By inhibiting HSD-1, SPI-62 is targeting a source of cortisol that is available to act within cells, and thereby potentially mitigating its negative effects.
Potential Benefits
High Efficacy
Previous clinical trials of SPI-62 showed potent targeting of HSD-1 in the brain and liver, and a corresponding lowering of intracellular cortisol levels in the liver. Furthermore, patients with Cushing’s and constitutionally low HSD-1 activity showed no symptoms of their severe hypercortisolism.¹ ²
Strong Safety
In five clinical trials, SPI-62 has demonstrated a favorable safety and tolerability profile with few adverse effects.
High Adherence
As a small molecule with predictable pharmacokinetics, SPI-62 is expected to be administered once daily without any need for complex monitoring.
No Titration
SPI-62 has demonstrated rapid and complete HSD-1 inhibition with oral administration at low doses that have been generally well tolerated with few side effects.
Future Plans
Phase 2 clinical trials of SPI-62 for patients with Cushing’s and ACS initiated in 2022.
¹ J Clin Endocrinol Metab (2002) 87:57-62.
² Endocrine J (2008) 55:709-715.