Sparrow Pharmaceuticals Presents Novel Data on Clofutriben (SPI-62) Reducing Glucocorticoid Toxicities with a Low Risk of Adrenal Insufficiency at the 2024 Annual Endocrine Society Conference
Portland, Oregon, June 4, 2024 — Sparrow Pharmaceuticals announced today that it presented interim analyses of ongoing clinical trials at the Endocrine Society (ENDO) 2024 Annual Conference held June 1-4, 2024. To date, the HSD-1 inhibitor clofutriben (SPI-62) has normalized urine free cortisol (UFC) in >60% of patients with endogenous Cushing’s syndrome (EnCS) without suppressing serum cortisol to levels considered to indicate risk for adrenal insufficiency (AI).
Medications for EnCS treatment that inhibit cortisol synthesis, antagonize cortisol production, or block cortisol’s interaction with its receptor must be titrated carefully along a spectrum between controlling the devastating morbidities of cortisol excess and risking the potentially fatal consequences of insufficient cortisol. The new data suggest that clofutriben might step off that spectrum, achieving efficacy without dose titration and with a low risk of AI.
In a symposium presentation, Sparrow’s Chief Scientific Officer Dr. David A. Katz described interim results from two separate Phase 2 clinical trials of clofutriben, for ACTH-dependent Cushing’s syndrome and, in combination with the steroid medicine prednisolone, for polymyalgia rheumatica, that support two important hypotheses:
HSD-1 inhibition, with an inhibitor such as clofutriben, can reduce active intracellular glucocorticoids that can bind to intracellular receptors and thereby reduce glucocorticoid toxicities.
HSD-1 inhibition can secondarily reduce active systemic glucocorticoids but with low risk of causing AI.
Sparrow’s Chief Medical Officer Dr. Frank S. Czerwiec added, “The Sparrow team looks forward to learning if these promising interim results hold for the larger number of patients in the now fully enrolled clinical trial in endogenous Cushing’s syndrome. In anticipation, our team is planning for the initiation of a Phase 3 trial in 2025. We’re grateful to patient participants and the investigators who are such important contributors to progress in Cushing’s research.”