Sparrow Pharmaceuticals Expands Phase 2 Clinical Trial of SPI-62 with Prednisolone for Polymyalgia Rheumatica with Second Cohort
08 Mar 2023
Phase 2Drug Approval
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 inhibitorHSD-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.
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