SPI-62/prednisolone

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 Phase 2 clinical trial (NCT number: NCT05436652) of prednisolone in combination with SPI-62 for the treatment of polymyalgia rheumatica (PMR) with the introduction of a second cohort to the study. “This trial is expected to teach us whether SPI-62 can separate the desired and undesired effects of prednisolone,” said David Katz, PhD, Chief Scientific Officer of Sparrow. “Since the first clinical use almost 75 years ago, a goal of rheumatologists has been to deliver the potent efficacy of glucocorticoids to control autoimmune and inflammatory disorders yet spare patients the adverse symptoms associated with those drugs.” “The management of conventional glucocorticoids includes giving as little as possible but as much as necessary,” said Prof. Dr. med Frank Buttgereit, Principle Investigator for the trial in Germany. “Another innovative way to potentially optimize treatment with these highly effective drugs derives from knowledge of their metabolism, or more precisely, HSD metabolism.” In this multi-center trial, multiple markers of prednisolone efficacy (e.g., erythrocyte sedimentation rate, C-reactive protein) and toxicity (e.g., oral glucose tolerance test, osteocalcin) will be measured in two 2-week periods during which patients will receive either SPI-62 or matching placebo in addition to prednisolone. Twelve additional patients will be enrolled in this second cohort. Patients with PMR taking a daily 10mg oral dose of prednisolone may be eligible for the trial. 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 PMR trial 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.

PORTLAND, Ore.--( BUSINESS WIRE )-- Sparrow Pharmaceuticals, a clinical-stage biopharmaceutical company developing novel, targeted therapies to address unmet needs in both endocrinology and rheumatology, today presented pharmacology data during an online poster session on SPI-62, a HSD-1 inhibitor, at the American College of Rheumatology (ACR) Convergence 2022 meeting. The presentation titled, “Toward Safer Glucocorticoid Therapy” examined the ability of SPI-62 to mitigate the adverse effects of exogenously administered corticosterone (CORT) in mouse, with results suggesting SPI-62 has the potential to prevent the adverse effects of glucocorticoids. “Patients with autoimmune conditions such as polymyalgia rheumatica rely on glucocorticoids such as prednisone. The effects of long-term use can be severe, including diabetes, cardiovascular disease, and muscle and skin atrophy. An effective glucocorticoid with fewer side effects would be a breakthrough for them,” said David A. Katz, Ph.D., CSO at Sparrow Pharmaceuticals. “The study data presented at ACR demonstrate that SPI-62 can prevent cardiometabolic, muscular, and dermal adverse side effects of CORT in mouse. That adds to the existing evidence that SPI-62 in combination with a glucocorticoid has potential to be effective, safe, convenient, and cost-effective treatment for patients with polymyalgia rheumatica and other rheumatic diseases. A Phase 2 clinical trial of prednisolone together with SPI-62 is ongoing.” CORT was administered to mice for 5 weeks. The animals were randomized to three different SPI- 62 regimens or vehicle. SPI-62 prevented CORT adverse effects of increased food consumption, accelerated body weight gain, skin atrophy, insulin resistance, skeletal myoatrophy, and reduced grip strength, each in a dose-dependent manner. SPI-62 is a potent HSD-1 inhibitor that is in a Phase 2 clinical trial with prednisolone for polymyalgia rheumatica, a prevalent autoimmune disease that mainly affects people over 50. 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-47, a fixed-dose-combination of SPI-62 and prednisolone, is in development. Additionally, SPI-62 is in Phase 2 clinical trials for Cushing’s syndrome and autonomous cortisol secretion. In Phase 1 clinical trials, SPI-62 was generally well tolerated and demonstrated maximal liver HSD-1 inhibition and brain HSD-1 occupancy. To view the abstracts, visit the ACR Convergence website here . To learn more about Sparrow Pharmaceuticals and its clinical pipeline, visit the website at www.sparrowpharma.com . About Sparrow Pharmaceuticals Sparrow Pharmaceuticals aims to spare patients the ravages of steroids. Leveraging underappreciated scientific insights into steroid 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. SPI-62, is an oral, small molecule, novel therapeutic treatment designed to target the source of active intracellular glucocorticoids in key tissues.