PORTLAND, Ore.--(BUSINESS WIRE)--Sparrow Pharmaceuticals, a clinical-stage biopharmaceutical company that develops novel, targeted therapies to address unmet needs in both endocrinology and rheumatology, will present interim data from the ongoing Phase 2 trial of lead agent clofutriben, a potent and selective HSD-1 inhibitor, in combination with prednisolone for the treatment of polymyalgia rheumatica (PMR) at the American College of Rheumatology Convergence 2024 conference November 14–19 at the Walter E. Washington Convention Center in Washington, D.C. Sparrow also announced that the trial has been expanded with a fifth cohort based on encouraging results from the first four cohorts.
The first abstract is titled “Hypothalamic-Pituitary-Adrenal Axis Suppression by Prednisolone Reversed by the 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor Clofutriben”. Key findings include that, in patients with polymyalgia rheumatica chronically treated with prednisolone, clofutriben increased morning ACTH and cortisol concentrations after 2 weeks of therapy, even with prednisolone dose increase. These data support a hypothesis that co-administration of HSD-1 inhibitors with glucocorticoids might mitigate risk of glucocorticoid-induced adrenal insufficiency.
The second abstract is titled “Clofutriben to Improve the Benefit-Risk Profile of Prednisolone in Patients with Polymyalgia Rheumatica”. The company found that in patients with PMR the combination of clofutriben and prednisolone 20 mg, compared to prednisolone 10 mg alone, showed an improved benefit-risk profile comprised of similar efficacy and less evidence of prednisolone toxicity.
Based on the encouraging findings from the first four cohorts, the ongoing Phase 2 trial has been expanded to a fifth cohort.
Clofutriben is a potent HSD-1 inhibitor that is in a Phase 2 clinical trial with prednisolone for polymyalgia rheumatica, a prevalent autoimmune disease that mainly affects people over 50. HSD-1 is an intracellular enzyme that activates glucocorticoids in target tissues in which glucocorticoid medicines are associated with morbidity including liver, adipose, muscle, and skin. SPI-47, a fixed-dose-combination of clofutriben and prednisolone, is in development. Additionally, clofutriben is in Phase 2 clinical trials for endogenous Cushing’s syndrome and autonomous cortisol secretion.
To view the abstracts, visit the ACR Convergence website here.
To learn more about Sparrow Pharmaceuticals and clofutriben visit www.sparrowpharma.com.
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, clofutriben (SPI-62), is an oral, small molecule, novel therapeutic treatment designed to target a source of active intracellular glucocorticoids in key tissues.
