Sparrow Pharmaceuticals Doses First Patient in Phase 2 Clinical Trial of SPI-62 with Prednisolone for Polymyalgia Rheumatica

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This trial will be the first to evaluate steroid efficacy and toxicity in patients with an autoimmune disease in the presence of a HSD-1 inhibitor.

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Friday, September 9, 2022
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Health, Other Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Cardiovascular disease, Osteocalcin, Insulin resistance, Osteoporosis, Patient, PMR, Polymyalgia rheumatica, Steroid, Dyslipidemia, Autoimmune disease, Vasculitis, Autoimmunity, Doctor of Philosophy, Toxicity, Rheumatology, Disease, Giant cell arteritis, Medication, C-reactive protein, Tissue, Pains, NCT, Glaucoma, Bruise, Endocrinology, Glucocorticoid, Skin, ACHES, Weight gain, Tissue (biology), Cortisone, Stroke, Hypertension, Aortic aneurysm, Bone loss, GCA, Myalgia, Risk, Motion, Diabetes, Insomnia, Muscle atrophy, Life, Degenerative disease, Prednisolone, Pharmaceutical industry, Dietary supplement
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POLYMYALGIA RHEUMATICA, SPARROW PHARMACEUTICALS
Summary
Key Points: 
  • This trial will be the first to evaluate steroid efficacy and toxicity in patients with an autoimmune disease in the presence of a HSD-1 inhibitor.
  • If we observe separation of the desired from undesired effects of prednisolone, well be an important step closer to solving a decades-old puzzle in autoimmune disease treatment.
  • Patients with PMR taking a daily 10mg oral dose of prednisolone may be eligible for the trial.
  • To learn more about Sparrow Pharmaceuticals and its clinical trials, visit the website at www.sparrowpharma.com .


Sparrow Pharmaceuticals, an emerging, clinical-stage biopharmaceutical company developing novel, targeted therapies to address unmet needs in both rheumatology and endocrinology, today announced that the first patient has been dosed in a phase 2 clinical trial (NCT number: NCT05436652) of prednisolone in combination with SPI-62, Sparrow’s potent and selective investigational HSD-1 inhibitor, for the treatment of polymyalgia rheumatica (PMR), a common autoimmune disease that causes widespread muscle pain and stiffness primarily in adults over 50. A fixed-dose combination of prednisolone and SPI-62 will be referred to as SPI-47.

“Millions of people with PMR must choose between living with the debilitating symptoms of their disease or suffering the severe side effects of glucocorticoid, or steroid, medicines such as prednisolone, as steroids are the only approved treatment,” said David Katz, PhD, Chief Scientific Officer of Sparrow. “Both clinical and animal study results suggest that SPI-62 can mitigate steroid adverse impact, such as insulin resistance, increased adiposity, muscle atrophy, and fracture risk, yet not meaningfully alter steroid efficacy to relieve inflammatory symptoms. This trial will be the first to evaluate steroid efficacy and toxicity in patients with an autoimmune disease in the presence of a HSD-1 inhibitor. If we observe separation of the desired from undesired effects of prednisolone, we’ll be an important step closer to solving a decades-old puzzle in autoimmune disease treatment.”

“Glucocorticoids (e.g. prednisolone, cortisone) are indispensable medicines worldwide. They work quickly, are universally applicable, inexpensive, and very effective. Unfortunately, their use has serious side effects,” said Dr. med. Andrea Everding, Hamburg Rheumatology Research Center. “Development of a well-tolerated glucocorticoid would be a groundbreaking discovery and could be a real breakthrough in the treatment of our patients. We are doing all we can to support this innovative development.”

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. Up to 48 patients will be enrolled. Six clinical sites in Germany are active. Patients with PMR taking a daily 10mg oral dose of prednisolone may be eligible for the trial.

To learn more about Sparrow Pharmaceuticals and its clinical trials, visit the website at www.sparrowpharma.com.

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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