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

2023-09-12

临床2期上市批准

PORTLAND, Ore.--(BUSINESS WIRE)-- 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 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. To learn more about Sparrow Pharmaceuticals and its clinical trials, visit the website at . About Polymyalgia Rheumatica Polymyalgia rheumatica (PMR) is the most common autoimmune disorder among the elderly. This condition is associated with aches and pains, primarily in the limbs, as well as stiffness in affected areas and a limited range of motion. Approximately 10-15% of patients with PMR are also diagnosed with giant-cell arteritis (GCA), which can cause sudden blindness, stroke, and aortic aneurysm. Currently, glucocorticoid (steroid) medicines such as prednisolone are the only approved treatments for PMR. While the efficacy response to steroids is often dramatic, even short-term administration of steroid medicines can cause serious toxicity. Therefore, once PMR symptoms are under control, the dose of steroids is gradually decreased. However, many patients subsequently experience a flare, requiring administration once again of higher doses of steroids. Some patients are able to stop taking steroids within a year, but others must continue to take them for the rest of their lives. Due to chronic administration of glucocorticoids, patients with PMR often suffer debilitating side effects including poor glucose control (diabetes), cardiovascular disease, hypertension, dyslipidemia, weight gain, sleeplessness, osteoporosis (bone loss), glaucoma, thinning of the skin, and bruising. The elderly population affected by PMR is at increased risk for, and can have more severe life impact from, glucocorticoid side effects compared to younger adults. 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, SPI-62, is an oral, small molecule, novel therapeutic treatment designed to target the source of active intracellular glucocorticoids in key tissues.

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