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

Sparrow Pharmaceuticals, a biopharmaceutical company in the clinical stage of development, has announced a collaboration with the University of Oxford and the University of Sheffield to conduct a Phase 2 clinical trial known as DC-MACS. This study focuses on the potential treatment of autonomous cortisol secretion (ACS) using clofutriben, also referred to as SPI-62. The trial is set to take place in the United Kingdom and is financially supported by the UK Research and Innovation Medical Research Council. Sparrow Pharmaceuticals is contributing to the study by supplying both clofutriben and a placebo.

Autonomous cortisol secretion is a significant health condition caused by the excessive production of cortisol due to a benign adrenal gland tumor. This overproduction leads to various health issues, making it an urgent area of research. The objective of the DC-MACS study is to explore the safety and efficacy of clofutriben, which is a potent and selective inhibitor of the enzyme HSD-1. This enzyme is responsible for activating cortisol in target tissues, contributing to various morbidities, including complications in the liver, muscle, and brain, as well as in adipose tissue.

The clinical trial is being led by two eminent figures in endocrinology: Professor Jeremy Tomlinson from the University of Oxford and Professor John Newell-Price from the University of Sheffield. Professor Tomlinson has an impressive background in HSD-1 research and has previously identified patients with Cushing’s tumor who did not exhibit symptoms of Cushing’s syndrome due to HSD-1 deficiency. Professor Newell-Price currently serves as the President of the Endocrine Society. The research will be hosted in clinical facilities at both Oxford and Sheffield, supported by the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Centre.

There is a growing concern within the medical community about the underdiagnosis of ACS, which often leaves patients vulnerable to severe health risks such as cardiovascular disease, bone fractures, and even increased mortality rates. Professor Tomlinson expressed optimism about the potential impact of the DC-MACS trial, suggesting it could pioneer a new intervention for ACS, thereby significantly improving patient outcomes and quality of life. Similarly, Professor Newell-Price emphasized the need to raise awareness about ACS and its associated risks through this study.

The trial will follow a randomized, double-blind, placebo-controlled format, involving 40 participants across two sites: Sheffield Teaching Hospitals NHS Foundation Trust and Oxford University Hospitals NHS Foundation Trust. The study aims to assess not only the effectiveness of clofutriben in reducing cortisol activation but also its impact on various endocrine markers. These markers include insulin sensitivity, glucose disposal, triglycerides, nighttime blood pressure, and bone health indicators like osteocalcin and CTX.

David Katz, Chief Scientific Officer at Sparrow Pharmaceuticals, highlighted the potential of clofutriben to become the first targeted therapy for ACS, a condition that is currently not widely recognized. By substantially lowering intracellular cortisol, clofutriben could address the factors contributing to the morbidity associated with ACS, offering hope for a new, effective treatment approach for this serious health issue.