Sparrow Pharmaceuticals Announces First Patient Dosed in RESCUE, a Phase 2 Clinical Trial of SPI-62 for Cushing’s Syndrome

Sparrow has also been granted SME status by the European Medicine Agency

PORTLAND, Ore.--(BUSINESS WIRE)--Sparrow Pharmaceuticals, a clinical-stage biopharmaceutical company developing novel, targeted therapies to address unmet needs in both endocrinology and rheumatology, today announced that the first patient has been dosed in the RESCUE trial, a phase 2 clinical trial of SPI-62, a potent and selective HSD-1 inhibitor, for the treatment of ACTH-dependent Cushing’s syndrome. This study is one of three phase 2 trials planned to investigate SPI-62 as a treatment for disorders of glucocorticoid excess.

“Dosing our first patient in this phase 2 trial is an important milestone in our clinical development process of SPI-62,” said Frank Czerwiec, MD, PhD, Chief Medical Officer of Sparrow. “Cushing’s is a devastating rare disease with debilitating morbidities such as depression, bone loss, and diabetes, and if left untreated, high levels of mortality. Current treatments have limited efficacy or serious side effects, so there is a pressing need for new treatments that help these patients mitigate the effects of hypercortisolism.”

The international, multicenter, randomized, double- and single-blind, placebo-controlled study is evaluating the pharmacologic effect, efficacy, and safety of SPI-62. The primary endpoint is to determine the pharmacologic effects of SPI-62 in patients with adrenocorticotropic hormone (ACTH)-dependent Cushing’s syndrome. This includes measurement of the body’s activation of cortisol in important target tissues such as the liver, which is expected to be inhibited by SPI-62. The study will also explore SPI-62’s safety and effect on and Cushing’s features that include hyperglycemia, dyslipidemia, adiposity, hepatic steatosis, hypertension, glaucoma, mood, sleep, pain, osteopenia, and muscle strength.

Sparrow is actively enrolling up to 26 patients for the trial, which is being conducted at 16 sites in the U.S., Bulgaria, and Romania. Criteria for participation include male and female subjects, ages 18 years or older, with active and consistent cortisol excess and documented diagnosis of ACTH-dependent Cushing’s syndrome.

The company has also been granted SME (small- and medium-sized enterprise) status by the European Medicines Agency (EMA), which allows Sparrow greater access to finance and EU support programs.

To learn more about the RESCUE trial (NCT05307328), please visit www.sparrowtrials.com.

About Cushing’s Syndrome and SPI-62

Patients develop Cushing’s syndrome due to an excess of glucocorticoids. In Cushing’s disease, this is due to a pituitary tumor that leads to high levels of adrenocorticotropic hormone, which stimulates excess cortisol secretion. ACTH, or its releasing hormone CRH, may also be produced by non-pituitary tumors. By targeting the intracellular activation of cortisol in key organs, SPI-62 can potentially mitigate multiple signs and symptoms of cortisol excess. HSD-1 inhibition would be the first new mechanism of action in decades to treat Cushing’s. In phase 1 studies, SPI-62 demonstrated the ability to reduce intracellular cortisol in the liver and to inhibit HSD-1 in both the brain and adipose tissue, which are three key tissues in which corticosteroid toxicity leads to morbidity.

About Sparrow Pharmaceuticals

Sparrow Pharmaceuticals was founded to spare patients the ravages of steroids. Leveraging underappreciated scientific insights into steroid biology, the company is working to provide better treatment options for serious disorders of hypercortisolism, and to revolutionize the treatment of autoimmune and inflammatory conditions. SPI-62, is an oral, small molecule, novel therapeutic treatment designed to target the source of active intracellular glucocorticoids in key tissues.