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 19th 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.