Sparrow Pharmaceuticals Expands PROST! with Fourth Cohort in Phase 2 Clinical Trial of SPI-62 with Prednisolone for Polymyalgia Rheumatica

Portland, Oregon, March 4, 2024 Sparrow Pharmaceuticals has continued to expand its PROST! Phase 2 clinical trial (NCT05436652) of SPI-62 in combination with prednisolone for the treatment of polymyalgia rheumatica (PMR) with a fourth cohort.

PMR is a common autoimmune disorder among the elderly for which glucocorticoid (steroid) medicines such as prednisone, until recently, were the only recommended treatment. While effective, steroids also have serious toxicities that cause diabetes, hypertension, weight gain, sleeplessness, and mood changes. Sparrow believes that SPI-62 could reduce the toxicity of steroids, allowing for effective treatment with less side effects.

“In the clinic, we’ve seen encouraging results with SPI-62, which supports the expansion of PROST! to include a new, fourth cohort,” said Dr. David Katz, Chief Scientific Officer of Sparrow. “We aim to allow physicians to continue to prescribe the steroids necessary to treat autoimmune diseases such as PMR, but with less concern about side effects.”

SPI-62 is Sparrow’s potent and selective investigational HSD-1 inhibitor. 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-62 is also in Phase 2 development for the treatment of endogenous Cushing’s syndrome and autonomous cortisol secretion (ACS). For the rheumatology program, a fixed-dose combination of prednisolone and SPI-62 will be referred to as SPI-47.   

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Sparrow Pharmaceuticals Doses First Patient in Phase 2 ACSpire Study of SPI-62 for Autonomous Cortisol Secretion