Sparrow Pharma Presents New Data on Clofutriben and Prednisolone for Polymyalgia Rheumatica at DGRh 2024

Sparrow Pharmaceuticals has recently unveiled promising new data from a Phase 2 clinical trial investigating the efficacy of their HSD-1 inhibitor, clofutriben (referred to as SPI-62 in the study), when used alongside prednisolone for treating polymyalgia rheumatica (PMR). The findings were presented at the German Congress of Rheumatology (DGRh Kongress 2024) in Dusseldorf, Germany, between September 18th and 21st, 2024.

David Katz, PhD, Chief Scientific Officer at Sparrow Pharmaceuticals, shared insights from the abstract titled “An 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor to Optimize the Effects of Prednisolone in Patients with Polymyalgia Rheumatica (PMR).” The primary focus was on clofutriben’s potential to mitigate or prevent the side effects associated with prednisolone while preserving its therapeutic benefits for PMR patients.

The clinical trial involved 40 participants diagnosed with PMR, who were administered varying doses of prednisolone (10 mg, 15 mg, or 20 mg) in combination with clofutriben 6 mg for a duration of two weeks. Additionally, the participants received prednisolone 10 mg with a placebo for clofutriben for another two weeks. Key results from the trial include:

- No relapses of PMR were observed in patients who received 15 mg or 20 mg doses of prednisolone in combination with clofutriben.
- The combination of 20 mg prednisolone with clofutriben was found to be as effective as 10 mg prednisolone with placebo, as determined by evaluating participants’ symptoms, physical function, and inflammation biomarkers.
- All tested doses of prednisolone, when combined with clofutriben, showed reduced glucocorticoid toxicity compared to the combination of prednisolone with placebo.

Dr. Katz emphasized the significance of these findings, stating, "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. 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."

Furthermore, Sparrow Pharmaceuticals has expanded its PROST! Phase 2 clinical trial (NCT05436652) to include a fifth cohort. This extension aims to further explore the combination of clofutriben and prednisolone in treating PMR, thereby continuing to study how clofutriben can maintain the efficacy of steroid medications without their severe side effects.

Sparrow Pharmaceuticals is dedicated to developing better treatment options for serious disorders of hypercortisolism and aims to revolutionize the treatment of autoimmune and inflammatory conditions. The company’s lead product, clofutriben (SPI-62), is an oral, small molecule therapeutic designed to target active intracellular glucocorticoids in key tissues, potentially offering significant benefits for patients.

By leveraging insights into glucocorticoid biology, Sparrow Pharmaceuticals strives to provide innovative solutions that address the needs of patients with conditions requiring steroid treatment, ensuring therapeutic benefits while minimizing adverse effects.