Sparrow Pharma Partners with Oxford and Sheffield for Clofutriben Phase 2 Study

PORTLAND, Ore.-- Sparrow Pharmaceuticals, a budding biopharmaceutical entity focused on innovative, targeted treatments to fulfill unmet medical needs in immunology and endocrinology, has embarked on a collaborative venture with the University of Oxford and the University of Sheffield. This alliance centers on the DC-MACS study, an investigator-led Phase 2 clinical trial in the UK, examining clofutriben (SPI-62) for managing autonomous cortisol secretion (ACS).

ACS is a condition characterized by excessive cortisol production due to a benign adrenal gland tumor. It is a significant health concern, as it often remains undiagnosed, putting individuals at risk for various health issues. This research initiative receives backing from the UK Research and Innovation Medical Research Council, with Sparrow supplying clofutriben and placebo for the study.

The trial is spearheaded by prominent figures in endocrinology: Professor Jeremy Tomlinson from the University of Oxford, known for his pioneering work on HSD-1, and Professor John Newell-Price from the University of Sheffield, who currently presides over the Endocrine Society. Professor Tomlinson is supported by the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Centre, facilitating the study through NIHR-supported clinical facilities in both Oxford and Sheffield.

Professor Tomlinson expressed optimism, stating, "In partnering with Sparrow for the DC-MACS trial, we hope to pioneer a completely novel intervention for this common, yet serious disease. If successful, this trial could provide patients with ACS with a treatment that could transform their health and quality of life."

Professor Newell-Price highlighted the current diagnostic challenges, noting, "ACS today usually goes undiagnosed. This leaves many patients at risk of morbidity from their hypercortisolism, including cardiovascular disease and bone fractures, and even a higher risk of death. Hopefully, we can not only demonstrate a new potential treatment, but also raise awareness of this dangerous disease."

The study is designed as a randomized, double-blind, placebo-controlled trial aimed at assessing the efficacy, safety, and pharmacological effects of clofutriben. Clofutriben is a novel, highly potent, and selective inhibitor of the enzyme HSD-1, which activates cortisol in tissues, contributing to various morbidities. The research will also measure endocrine markers such as insulin sensitivity, glucose disposal, triglycerides, night-time blood pressure, and bone biomarkers like osteocalcin, P1NP, and CTX. The trial will include 40 participants across two sites: Sheffield Teaching Hospitals NHS Foundation Trust and Oxford University Hospitals NHS Foundation Trust.

David Katz, Chief Scientific Officer of Sparrow, remarked, "Clofutriben substantially lowers intracellular cortisol, which can bind intracellular receptors and thereby cause the morbidity associated with ACS. Clofutriben has potential to be the first targeted therapy for that common, serious, and currently underrecognized disease."

Autonomous cortisol secretion arises from excessive cortisol production in the adrenal gland due to a tumor. Unlike Cushing’s syndrome, ACS lacks distinct clinical features, leading to misdiagnosis as common chronic conditions. Diagnosis often occurs incidentally during scans for unrelated health issues, followed by endocrine evaluations. Due to infrequent diagnosis, patients may endure elevated cortisol levels for extended periods, resulting in severe health complications, increased healthcare expenses, and heightened risk of premature death. Symptoms span a range of mental and physical effects, including diabetes, hypertension, bone fractures, weight gain, and issues related to mood, cognition, and sleep. Currently, no established drug treatment exists for ACS; recent European guidelines advocate monitoring for complications rather than active treatment.

Sparrow Pharmaceuticals was established to mitigate the adverse effects of steroids. By leveraging insights into glucocorticoid biology, the company aims to improve treatment options for hypercortisolism and revolutionize the management of autoimmune and inflammatory conditions. Its flagship product, clofutriben, is an orally administered small molecule therapy designed to target active intracellular glucocorticoids in crucial tissues.