Sparrow Pharmaceuticals Doses First Patient in Phase 2 ACSpire Study of SPI-62 for Autonomous Cortisol Secretion

2023-10-24

临床2期

Initial data from the clinical trial is expected in 2024 PORTLAND, Ore.--(BUSINESS WIRE)-- Sparrow Pharmaceuticals, an emerging, clinical-stage biopharmaceutical company developing novel, targeted therapies to address unmet needs in both rheumatology and endocrinology, today announced that the first patient has been dosed in the Phase 2 ACSpire study (NCT number: NCT05436639) of SPI-62, a potent and selective HSD-1 inhibitor HSD-1 inhibitor, for the treatment of autonomous cortisol secretion (ACS), a prevalent yet serious condition caused by the overproduction of cortisol from a benign tumor of the adrenal gland. This trial will complement the ongoing Phase 2 RESCUE study (NCT number: NCT05307328) for the treatment of ACTH-dependent Cushing’s syndrome. “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,” said Frank Czerwiec, chief medical officer of Sparrow. “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 tumor 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.” The pilot, long-term, open-label study is evaluating the efficacy, safety, and pharmacological effect of SPI-62 in participants with hypercortisolism related to a benign adrenal tumor. The study will examine SPI-62's effect on morbidities of hypercortisolism including diabetes or impaired glucose tolerance, hyperlipidemia, hypertension, and osteopenia. Sparrow is actively enrolling up to 30 participants in ACSpire at sites in the United States, soon to be joined by sites in Romania, France, and the United Kingdom. Criteria for participation include adults with documented benign adrenal lesions with proven ACS, and documentation of treatment for, or evidence of, ongoing metabolic consequences for at least one of the following: hyperglycemia, hypertension, hyperlipidemia, or osteopenia, attributable to clinically significant hypercortisolism. Surgery as first-line therapy should be discussed with all eligible participants, who will be included only if they have failed or rejected available surgical therapy. To learn more about Sparrow Pharmaceuticals and its clinical trials, visit the website at . About 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 syndrome, which is differentiated by a characteristic constellation of signs and symptoms. As patients with ACS lack these outward clinical features of Cushing’s but present with common, chronic conditions (diabetes, hypertension, high cholesterol, weakened bones), it is rarely diagnosed or addressed specifically. ACS is currently only discovered when the tumor shows up on a radiology 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. About Sparrow Pharmaceuticals Sparrow Pharmaceuticals was founded to spare patients the ravages of steroids. Leveraging underappreciated scientific insights into glucocorticoid 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. Its lead product, SPI-62, is an oral, small molecule, novel therapeutic treatment designed to target the source of active intracellular glucocorticoids in key tissues.

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