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The second phase of Cushing’s syndrome study investigated lead therapy targeting the main source of cortisol toxicity
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Sparrow’s leading proprietary small molecule SPI-62 reduces intracellular cortisol, which is the main cause of Cushing’s syndrome.
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In the previous four clinical trials, SPI-62 was associated with very few, mainly minor side effects.
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In subjects with diabetic peripheral neuropathy, SPI-62 has a clinically significant separation compared to placebo on HbA1c, glucose, cholesterol, and triglycerides.
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The company plans to use SPI-62 for multiple Phase 2 trials in the next 12 months.
Sparrow PharmaceuticalIs an emerging clinical-stage biopharmaceutical company dedicated to the development of new targeted therapies for steroid overdose diseases, and will be held from May 22 to 26, 2021 at the European Endocrinology Conference from May 22 to 26, 2021 (E-ECE 2021) made a new presentation, “SPI-62: An investigational HSD-1 inhibitor for the treatment of Cushing’s syndrome.” The speech summarized the company’s main therapeutic drug SPI-62 (a Oral, small molecule, the mechanism of action, safety and preliminary efficacy of a novel 11β-hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor. The poster also introduced the second phase of Cushing’s syndrome (CS) international multi-center clinical trial, which is scheduled to start later in 2021.
Excessive cortisol in CS mainly causes toxicity through interaction with intracellular receptors. Sparrow’s novel approach to CS is based on the recognition that the main source of intracellular cortisol is HSD-1. SPI-62 is a potent and selective HSD-1 inhibitor that has been shown to reduce intracellular cortisol in the liver by 90%.
The results of four phase 1 and phase 2 clinical trials that applied SPI-62 to 165 patients showed that:
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Pharmacokinetics support once a day orally.
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Sufficient and sustained intracellular cortisol reduction in the liver and target participation in the brain.
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At the expected clinical dose or higher, it usually has good safety and tolerability.
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In subjects with peripheral diabetic neuropathy, at six weeks, the HbA1c separation rate from placebo was 0.5%, glucose was 1.64 mM, cholesterol was 0.77 mM, and triglycerides were 0.42 mM.
Dr. David Katz, Chief Scientific Officer of Sparrow, said: “Excessive cortisol that harms patients with Cushing’s syndrome can enter the intracellular pool of intracellular receptors. This is mainly formed by HSD-1.” “SPI-62 can be reduced at most. 90% of the blood bank is related to clinical changes in diabetic patients. We are pleased to learn how these data bring clinical benefits to patients with Cushing syndrome, because patients with Cushing syndrome have excessive cortisol and are the main cause of their disease. ”
The planned Phase 2 double-blind, randomized, placebo-controlled international trial of SPI-62 for CS will start recruiting later in 2021. The following conditions: Type 2 diabetes, impaired glucose tolerance or hyperlipidemia.
Robert Jacks, President and CEO of Sparrow, said: “SPI-62 has the potential to address the destructive effects of overdose of steroids in several different patient populations.” “At the same time as this CS trial, we plan to One trial was conducted in patients with autonomous cortisol secretion, and another trial was conducted in another patient taking steroids for rheumatoid polymyalgia. Our recently completed Series A financing provides an opportunity to quickly It proves that the drug has potentially transformative advantages. It can solve the toxicity of excessive intracellular glucocorticoids by inhibiting HSD-1.”
About Mahjong Pharmaceutical
Sparrow Pharmaceuticals was established to protect patients from the destruction of steroids. Using scientific insights that are insufficiently understood in the biology of corticosteroids, the company is committed to providing better treatment options for severe hypercortisolism and innovating the treatment of autoimmune and inflammatory diseases. Its main product, SPI-62, is a new oral small molecule therapeutic drug designed to target the source of active intracellular glucocorticoids in key tissues.
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