Clofutriben

PORTLAND, Ore.--( BUSINESS WIRE )-- Sparrow Pharmaceuticals today announced that it presented new data from its ongoing Phase 2 clinical trial of its HSD-1 inhibitor, clofutriben (referred to SPI-62 in the study), in combination with prednisolone for the treatment of polymyalgia rheumatica (PMR) at the German Congress of Rheumatology (DGRh Kongress 2024) in Dusseldorf, Germany on 18 – 21 September, 2024. The data was presented in an oral presentation that took place on Thursday, September 19 th at 3:25PM CEST and a poster session. David Katz, PhD, Chief Scientific Officer at Sparrow discussed the abstract titled “ An 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor to Optimize the Effects of Prednisolone in Patients with Polymyalgia Rheumatica (PMR) .” Key findings were highlighted from the trial, which investigated the potential of clofutriben to reduce or prevent side effects of prednisolone while maintaining its effectiveness in PMR patients. The trial included 40 participants with confirmed PMR who were given prednisolone 10 mg, 15 mg, or 20 mg together with clofutriben 6 mg for 2 weeks. Patients also were given prednisolone 10 mg with placebo for clofutriben for 2 weeks. Result highlights are: No PMR relapses occurred when prednisolone 15 mg or 20 mg was co-administered with clofutriben. A combination of prednisolone 20 mg with clofutriben showed similar efficacy as prednisolone 10 mg with placebo, based on analysis of participants’ symptoms, physical function, and biomarkers of inflammation. All prednisolone doses in combination with clofutriben showed less glucocorticoid toxicity compared to prednisolone with placebo. "The data suggest that by using an HSD-1 inhibitor like clofutriben, we may be able to improve the balance between the therapeutic benefits and side effects of glucocorticoid therapy in patients with PMR," said Dr. Katz. "These encouraging findings support Sparrow’s innovative approach to develop treatments that may spare patients from the negative effects of glucocorticoid use, while maintaining the therapeutic benefits. This could potentially offer a new treatment paradigm for patients with rheumatic diseases and the many other conditions treated with glucocorticoids." Additionally, Sparrow has expanded its PROST! Phase 2 clinical trial ( NCT05436652 ) with a fifth cohort to explore clofutriben in combination with prednisolone for the treatment of PMR. This will allow for the continued study of how clofutriben can maintain the efficacy of steroid medicines without the harsh side effects. To learn more about Sparrow Pharmaceuticals and clofutriben (SPI-62), 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.

PORTLAND, Ore.--(BUSINESS WIRE)-- Sparrow Pharmaceuticals today presented data from an ongoing Phase 2 clinical trial of HSD-1 inhibitor clofutriben (SPI-62) and prednisolone in patients with polymyalgia rheumatica (PMR) at the 2024 Annual European Alliance for Associations for Rheumatology (EULAR 2024; June 12 – 15 in Vienna, Austria) that suggest HSD-1 inhibition can allow for effective treatment with glucocorticoid medicines with fewer side effects. A highlighted session, “75th Anniversary of Glucocorticoids – what have we learnt?” discussed recent clinical developments and key learnings from the use of glucocorticoids over the past 75 years. David Katz, PhD, Chief Scientific Officer at Sparrow, presented findings on the impact that co-administration of an HSD-1 inhibitor (clofutriben) with a glucocorticoid medicine (prednisolone) has on efficacy and glucocorticoid toxicity in patients with PMR. The findings highlight: Prednisolone 10mg combined with clofutriben 6mg demonstrated less efficacy compared to prednisolone 10mg administered with placebo, but with improvement on prednisolone toxicities (bone formation and resorption biomarkers, lipidemia, and insulin resistance.) Prednisolone 20mg combined with clofutriben 6mg demonstrated similar efficacy as determined by symptoms, physical function, and systemic inflammation, while maintaining improvement on markers of prednisolone toxicity, compared to prednisolone 10mg administered with placebo. “These new results suggest that glucocorticoids formed by HSD-1 have a large role in tissues where glucocorticoid excess causes morbidity, and a lesser role in the immune system where glucocorticoid medicines have efficacy,” said Dr. Katz. “We hope future clinical trials will demonstrate that prednisolone combined with clofutriben can be the effective and safe glucocorticoid medicine for which patients have waited over 75 years.” To learn more about Sparrow Pharmaceuticals and clofutriben (SPI-62), visit . 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. View source version on businesswire.com: Contacts Alexis Feinberg ICR Westwicke Alexis.Feinberg@westwicke.com 203-939-2225 Source: Sparrow Pharmaceuticals View this news release online at: