Sparrow Pharma Shares Phase 2 Trial Data on Clofutriben and Prednisolone for Polymyalgia Rheumatica at EULAR 2024

Sparrow Pharmaceuticals, headquartered in Portland, Oregon, has presented promising data from their ongoing Phase 2 clinical trial involving HSD-1 inhibitor clofutriben (SPI-62) and prednisolone for the treatment of polymyalgia rheumatica (PMR). The findings were shared at the 2024 Annual European Alliance for Associations for Rheumatology (EULAR 2024) held from June 12 to 15 in Vienna, Austria. The data suggest that HSD-1 inhibition could enable effective glucocorticoid treatment with reduced side effects.

During the event, a session titled “75th Anniversary of Glucocorticoids – what have we learnt?” delved into recent clinical advancements and the extensive learnings from seven decades of glucocorticoid use. David Katz, PhD, the Chief Scientific Officer at Sparrow, presented key findings on the effects of co-administering an HSD-1 inhibitor (clofutriben) with a glucocorticoid (prednisolone) on efficacy and toxicity in PMR patients. The study's results are significant for several reasons:

Firstly, when prednisolone 10mg was combined with clofutriben 6mg, there was a noticeable reduction in efficacy compared to prednisolone 10mg with a placebo. However, this combination improved prednisolone-related toxicities, such as bone formation and resorption markers, lipidemia, and insulin resistance.

On the other hand, prednisolone 20mg combined with clofutriben 6mg maintained similar efficacy in terms of symptoms, physical function, and systemic inflammation compared to prednisolone 10mg with a placebo. Importantly, this combination also showed improvements in markers of prednisolone toxicity.

Dr. Katz emphasized the significance of these findings, stating, “These new results suggest that glucocorticoids formed by HSD-1 play a significant role in tissues where excess glucocorticoids cause morbidity and a lesser role in the immune system where these medicines have their therapeutic effects." He expressed hope that future clinical trials would further validate the safety and efficacy of combining prednisolone with clofutriben, potentially offering patients a glucocorticoid treatment option that has been long awaited.

Sparrow Pharmaceuticals was established to alleviate the harmful effects of steroid treatments. By leveraging novel scientific insights into glucocorticoid biology, the company aims to provide improved treatment options for serious hypercortisolism disorders and to revolutionize the management of autoimmune and inflammatory conditions. Clofutriben (SPI-62), the company’s leading product, is an oral, small molecule therapy designed to target active intracellular glucocorticoids in critical tissues.

In summary, Sparrow Pharmaceuticals' research showcases a potential breakthrough in glucocorticoid therapy for PMR patients. The combination of clofutriben with prednisolone could potentially offer an effective treatment with fewer side effects, marking a significant advancement in the field of rheumatology.