Sparrow Pharmaceuticals Announces FDA Clearance of IND for SPI-62 for the Treatment of Cushing’s Disease

PORTLAND, Ore.–()–Sparrow Pharmaceuticals, an emerging, clinical-stage biopharmaceutical company developing novel, targeted therapies for disorders of corticosteroid excess, today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug Application (IND) that enables the company to proceed with initiating a phase 2 clinical trial to study SPI-62, a potent and selective investigational HSD-1 inhibitor, for the treatment of Cushing’s disease (CD). Having received clearance for the IND, Sparrow plans to begin enrolling patients in early 2022. This is the first of three phase 2 trials planned to investigate SPI-62 as a treatment for disorders of corticosteroid excess.

Patients develop Cushing’s due to an excess of corticosteroids. In CD, this is due to a tumor that leads to high levels of ACTH, which stimulates excess cortisol secretion. By targeting the intracellular activation of cortisol in key organs, SPI-62 can potentially mitigate multiple signs and symptoms of cortisol excess. HSD-1 inhibition would be the first new mechanism of action in decades to treat Cushing’s. In phase 1 studies, SPI-62 demonstrated the ability to reduce intracellular cortisol in the liver and to inhibit HSD-1 in both the brain and adipose tissue, which are three key tissues in which corticosteroid toxicity leads to morbidity.

“We are moving rapidly to initiate enrollment in this international clinical trial to study whether SPI-62 can represent an entirely new way to treat Cushing’s,” said Frank Czerwiec, chief medical officer of Sparrow. “Current treatments either have limited efficacy or serious side effects, so new therapeutic options are sorely needed for this devastating disease.”

In addition to the trial in Cushing’s disease, the company plans to initiate phase 2 trials in autonomous cortisol secretion (ACS) and polymyalgia rheumatica (PMR) by mid-2022. ACS is a common yet serious condition of cortisol excess caused by a functioning adrenal tumor. PMR is a debilitating autoimmune disease treated with glucocorticoids (GC) such as prednisolone. In combination with a GC, SPI-62 may mitigate GC side effects while not significantly impacting GC efficacy.

To enable execution of three simultaneous phase 2 trials Sparrow has expanded its clinical capabilities by hiring Kim Hunsicker as Head of Clinical Operations and Sarah Hooper as Clinical Project Manager. Ms. Hunsicker is a Certified Registered Nurse Practitioner with over 20 years of experience in driving clinical operations throughout all phases of drug development. She is also an Adjunct Assistant Professor of Clinical Research & Leadership at George Washington University. Ms. Hooper has a long track record of on-the-ground interaction with site research teams and extensive experience with management of all aspects of clinical studies.

Robert Jacks, President and chief executive officer of Sparrow, added, “We are thrilled to welcome Kim and Sarah as we continue to build our clinical execution capabilities. With the clearance of this IND we are now well positioned to accelerate our plans to generate proof-of-concept for SPI-62 in multiple indications.”

To learn more about Sparrow Pharmaceuticals and its leadership team, 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 corticosteroid 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 corticosteroids in key tissues.

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