Sparrow Pharmaceuticals, a clinical-stage biopharmaceutical company focused on endocrinology and rheumatology, presented interim Phase 2 trial data for clofutriben at the American College of Rheumatology Convergence 2024. Clofutriben, a potent and selective HSD-1 inhibitor, is being investigated in combination with prednisolone for treating polymyalgia rheumatica (PMR). Due to promising results from the initial four cohorts, a fifth cohort has been added to the trial.
One abstract highlighted clofutriben’s impact on the hypothalamic-pituitary-adrenal (HPA) axis suppression caused by prednisolone. In PMR patients undergoing chronic prednisolone treatment, clofutriben increased morning ACTH and cortisol levels after two weeks, even with increased prednisolone dosages. This suggests that HSD-1 inhibitors, when co-administered with glucocorticoids, may mitigate the risk of glucocorticoid-induced adrenal insufficiency.
A second abstract focused on the combined benefit-risk profile of clofutriben and prednisolone in PMR patients. The combination of clofutriben with 20mg of prednisolone demonstrated a superior benefit-risk profile compared to 10mg of prednisolone alone, exhibiting similar efficacy with reduced signs of prednisolone toxicity.
Clofutriben targets HSD-1, an intracellular enzyme that activates glucocorticoids in tissues where glucocorticoid medications can cause adverse effects, such as the liver, adipose tissue, muscles, and skin. PMR, a prevalent autoimmune disease primarily affecting individuals over 50, is the focus of this Phase 2 trial. SPI-47, a fixed-dose combination of clofutriben and prednisolone, is also under development. Furthermore, clofutriben is undergoing Phase 2 trials for endogenous Cushing’s syndrome and autonomous cortisol secretion.
Sparrow Pharmaceuticals aims to develop improved treatments for hypercortisolism and revolutionize the management of autoimmune and inflammatory conditions. Their focus lies in leveraging insights into glucocorticoid biology. Clofutriben (SPI-62), their lead product, is an oral, small molecule therapeutic targeting the source of active intracellular glucocorticoids in key tissues.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
