Sparrow Pharmaceuticals Initiates Third Cohort in PROST!, Phase 2 Clinical Trial of SPI-62 with Prednisolone for Polymyalgia Rheumatica

Portland, Oregon, September 12, 2023 Sparrow Pharmaceuticals, an emerging, clinical-stage biopharmaceutical company developing novel, targeted therapies to address unmet needs in both rheumatology and endocrinology, has expanded its PROST! Phase 2 clinical trial (NCT number: NCT05436652) of SPI-62 in combination with prednisolone for the treatment of polymyalgia rheumatica (PMR) to include a third cohort.

“Patients are excited to participate in this trial,” said Prof. Dr. med. Herbert Kellner, an investigator for the trial in Germany. “A product that provides the potent efficacy of prednisolone without many of the side effects that limit its utility would make a large difference in their lives.”

“We hypothesize that HSD-1 inhibition with SPI-62 can reduce the unwanted side effects of steroid medicines by lowering active steroid levels inside cells where steroids are known to cause toxicity,” said Dr. David Katz, Chief Scientific Officer of Sparrow. “Building upon the results seen in the first two cohorts, the third cohort is designed to expand our understanding of how to use SPI-62 in combination with prednisolone.”

SPI-62 is Sparrow’s potent and selective investigational HSD-1 inhibitor that is also in Phase 2 development for Cushing’s syndrome and autonomous cortisol secretion, in addition to PMR. For the rheumatology program, a fixed-dose combination of prednisolone and SPI-62 will be referred to as SPI-47. HSD-1, an intracellular enzyme, activates glucocorticoids in target tissues in which glucocorticoid medicines are associated with morbidity including liver, adipose, muscle, and skin.

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

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Sparrow Pharmaceuticals Announces First Patient Rolled-Over to Open-Label Extension of RESCUE, a Phase 2 Clinical Trial of SPI-62 for ACTH-Dependent Cushing’s Syndrome