PIPELINE & PROGRAMS

Sparrow is developing novel therapies that utilize HSD-1 inhibition to address unmet needs in endocrinology and rheumatology.

 

SPI-62

SPI-62 is an oral, small molecule, highly potent and selective new chemical entity HSD-1 inhibitor. It is in development to treat conditions of cortisol excess including endogenous Cushing’s syndrome (Cushing’s) and autonomous cortisol secretion (ACS).

In five clinical trials, SPI-62 demonstrated potent targeting of HSD-1 in the brain and liver, and significant lowering of cortisol levels in the liver. These studies also showed a favorable safety and tolerability profile, as well as improvement in glucose, HbA1c, cholesterol, and triglycerides.

SPI-47

SPI-47 is a combination of our proprietary HSD-1 inhibitor SPI-62 and the glucocorticoid (steroid) medication prednisolone. This combination has the potential to deliver the efficacy of the best steroids and safety comparable to top biologics.

While SPI-47 is being developed first for polymyalgia rheumatica (PMR), it may also benefit patients who rely on steroid medicines to treat other diseases.

Steroid excess produced by the body.

Cortisol is a natural steroid that is secreted by the adrenal gland. It is essential for maintaining many normal physiologic processes.

However, when produced in excess, cortisol can have adverse effects on the very same organs it helps function. Long-term elevated exposure often leads to a range of devastating health conditions.

 
increased mortality risk in patients with Cushing’s syndrome after surgical “cure”¹

increased mortality risk in patients with Cushing’s syndrome after surgical “cure”¹

Endogenous Cushing’s Syndrome (Cushing’s)

Cushing’s is a rare, severe condition caused by a tumor that produces or results in the production of excessive cortisol. Patients with Cushing’s often endure toxic cortisol levels and devastating symptoms for many years, leading to poor health outcomes and increased risk of early death. This disorder is currently treated by surgery and therapies with limited efficacy and serious side effects.

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prevalence of spinal fracture in patients with ACS²

prevalence of spinal fracture in patients with ACS²

Autonomous Cortisol Secretion (ACS)

ACS is a common yet serious condition caused by a tumor of the adrenal gland that produces excess cortisol, which can lead to debilitating symptoms, poor health outcomes, and risk of early death. This disorder is infrequently diagnosed as its symptoms are common to other diseases. Even if diagnosed, as of now, surgical removal of the tumor is the only recommended treatment.

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of patients on corticosteroid medicines experience an adverse event²

of patients on steroid medicines experience an adverse event²

Steroid excess from medication.

Glucocorticoid (steroid) medicines are cortisol analogues commonly used to treat patients with inflammatory and autoimmune diseases, cancer, transplanted organs, as well as a wide variety of other disorders. Though highly effective at treating a wide variety of conditions, they are associated with the same severe adverse effects as excess cortisol produced by the body.

 

Polymyalgia Rheumatica (PMR)

PMR is a common autoimmune disease among the elderly, causing widespread muscle pain and stiffness. Today, it is primarily treated with steroid medicines. Though highly effective at relieving pain and stiffness, steroid medicines cause side effects that can be so unbearable, many patients choose to just live with the symptoms of their disease.

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History of Steroid Treatments

When the first steroid medicine was discovered in 1948, it was a breakthrough success. But once its extreme side effects became apparent, scientists began searching for a way to separate the desirable and undesirable effects. For the last 70 years, they’ve been unsuccessful – we believe we’ve solved the puzzle.

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¹ Chiodini, I, et al. Eur J Endocrinol, 2016. https://pubmed.ncbi.nlm.nih.gov/27412441/

² Fardet, L. The British Journal of Dermatology, 2007. https://doi.org/10.1111/j.1365-2133.2007.07950.x