Results indicate that SPI-62 has the potential to mitigate adverse effects of glucocorticoid medications
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, today presented new animal model data during an in-person poster session titled, “Toward Safer Glucocorticoid Therapy of Polymyalgia Rheumatica” at the 2022 Annual European Congress of Rheumatology (EULAR 2022). Researchers studied the ability of Sparrow’s therapeutic candidate SPI-62, a HSD-1 inhibitor, to mitigate the adverse effects of exogenously administered corticosterone (CORT) in mouse.
The results of the study suggest that SPI-62 has the potential to mitigate adverse effects of glucocorticoids. SPI-47, a fixed-dose-combination of SPI-62 and prednisolone, is in clinical development for autoimmune and inflammatory diseases. A Phase 2 trial in patients with polymyalgia rheumatica (PMR), a prevalent autoimmune disease that mainly affects people over 50, is planned to initiate this month.
“Glucocorticoids such as prednisone are the mainstay of treatment for PMR. However, their use is limited by severe side effects such as diabetes, cardiovascular disease, osteoporosis, and hypertension. An effective glucocorticoid with fewer side effects would be a boon for patients,” said David A. Katz, Ph.D., CSO at Sparrow Pharmaceuticals. “Our demonstration that SPI-62 prevented cardiometabolic, muscular, and dermal adverse side effects of CORT in mouse adds to the existing evidence that a HSD-1 inhibitor has potential to mitigate glucocorticoid side effects whilst maintaining glucocorticoid efficacy. It’s exciting to have the opportunity to assess that hypothesis in Sparrow’s upcoming clinical trial. We aim for a future in which patients with PMR can control their disease without debilitating side effects.”
SPI-62 prevented several CORT adverse effects, demonstrating that by blocking local intracellular glucocorticoid activation with a HSD-1 inhibitor in target tissues, it can mitigate glucocorticoid toxicity:
- CORT resulted in increased food consumption which was normalized by SPI-62 in a dose-dependent manner;
- CORT-treated mice showed reduced body weight gain for two weeks and then accelerated weight gain; however, SPI-62 prevented body weight gain acceleration in a dose-dependent manner;
- CORT effects on dermal thickness and structure were less prominent in mice who received SPI-62; and
- SPI-62 prevented CORT adverse effects of insulin resistance, increased adiposity, skeletal myoatrophy, and grip strength reduction.
SPI-62 is a potent HSD-1 inhibitor entering Phase 2 development for Cushing’s syndrome and autonomous cortisol secretion, and also as adjunctive therapy to prednisolone in PMR. HSD-1, an intracellular enzyme, activates glucocorticoids in target tissues in which glucocorticoid medicines are associated with morbidity including liver, adipose, muscle, and skin. In Phase 1 clinical trials SPI-62 was generally well tolerated and demonstrated maximal liver and brain HSD-1 inhibition.
To register and view the abstracts, visit EULAR’s website here.
To learn more about Sparrow Pharmaceuticals and its clinical pipeline, visit the website at www.sparrowpharma.com.
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.
Contacts
Alexis Feinberg
ICR Westwicke
Alexis.Feinberg@westwicke.com
203-939-2225