Clofutriben

BOSTON, Feb. 02, 2026 (GLOBE NEWSWIRE) -- Sparrow Pharmaceuticals , a targeted cardiometabolic therapeutics company, today announced the appointment of Carlo Incerti, M.D., to its Board of Directors, effective January 1, 2026. Dr. Incerti is a highly accomplished executive with a strong background in medicine and over 35 years of strategic experience in the biopharmaceutical industry. “Carlo’s appointment comes at a pivotal moment for Sparrow as we are looking ahead to pivotal trials of clofutriben for type 2 diabetes and seeking to expand development into other cardiometabolic indications,” said Robert Jacks, Sparrow President and Chief Executive Officer. “Carlo is respected globally for his impressive track record of guiding successful development and commercialization of impactful therapies. His decision to join Sparrow signals strong scientific and medical validation of our approach from a recognized industry leader.” Dr. Incerti added, “Sparrow is pioneering a new mechanism of action to tackle a common driver of metabolic dysfunction that current standard-of-care therapies do not address. By lowering intracellular cortisol specifically in patients demonstrating evidence and consequences of having elevated cortisol, HSD-1 inhibition with clofutriben could allow treatment to progress from one-size-fits-all to targeting a specific pathogenic cause of disease progression. Having already demonstrated not only encouraging evidence of glycemic control improvement, but also suggestion of benefit on other cardiometabolic parameters such as weight, blood pressure, and lipids, all without significant safety or tolerability concerns so far, clofutriben’s clinical pro incredibly exciting and could strongly contribute to reaching therapeutic goals in these patients.” Dr. Incerti currently serves as an Operating Partner at Forbion and brings over three decades of experience in the biopharmaceutical industry. He most recently held the position of Senior Vice President, Chief Medical Officer and Head of Global Medical Affairs at Sanofi Genzyme. Prior to joining industry, Dr. Incerti was an Associate Professor of Endocrinology at the University of Modena, with a main research focus on thyroid diseases and sex hormones. Dr. Incerti currently serves as Chairman of the Board at Numab Therapeutics AG and Chairman of the Board at Azafaros B.V. He also serves as a member of the board of directors of Dyne Therapeutics Inc. (Nasdaq: DYN) and Synox Therapeutics Ltd. Dr. Incerti is a Founding Member of IRDiRC, the International Rare Diseases Research Consortium. He previously served as Chairman of the Board of Inversago Pharma, which was sold to Novo Nordisk in 2023, and of Yellow Jersey Therapeutics, a spin-off from Numab Therapeutics, which was sold to Johnson & Johnson in 2024. About Sparrow Pharmaceuticals Sparrow Pharmaceuticals is a targeted cardiometabolic therapeutics company delivering breakthrough solutions for the millions of patients who struggle to control metabolic dysfunction with current therapies. The company’s lead candidate, clofutriben, is a once-daily, oral HSD-1 inhibitor in late-stage development for type 2 diabetes with elevated cortisol. HSD-1 inhibition is a novel mechanism that complements existing antidiabetic agents by addressing a common cause of disease progression and treatment resistance across a spectrum of metabolic dysfunction. Clofutriben has been associated with improved glycemic control and other metabolic benefits while generally safe and well tolerated in multiple clinical trials without requiring dose titration. To learn more, visit or follow us on LinkedIn . Media Contact Maggie Whitney LifeSci Communications mwhitney@lifescicomms.com

Clofutriben is a novel, once-daily, oral HSD-1 inhibitor that reduces excess intracellular cortisol, a new precision approach to a common underlying driver of metabolic dysfunction PORTLAND, Ore., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Sparrow Pharmaceuticals , a targeted cardiometabolic therapeutics company, today announced that the first patient has been enrolled in its new Phase 2b clinical trial ( CAPTAIN-T2D, NCT07296484 ) evaluating clofutriben to improve glycemic control and metabolic health in patients who have difficult-to-control type 2 diabetes (T2D) with elevated cortisol (EC), a prevalent population with high unmet needs. CAPTAIN-T2D is a two-part trial. In the first part, patients with poorly controlled T2D despite being on multiple antidiabetic medications will be screened for EC using a simple overnight dexamethasone suppression test. Eligible participants with EC will be randomized to one of several doses of clofutriben or placebo in the dose-ranging, interventional second part of the trial. The primary endpoint is change in hemoglobin A1c (HbA1c) at 24 weeks. Exploratory endpoints will assess changes in other cardiometabolic parameters that can be impacted by EC including body weight, blood pressure, cholesterol, and bone formation markers. “Cardiovascular disease, often driven by metabolic dysfunction, remains the leading cause of death in both the US and Europe,” said Robert Jacks, Sparrow President and Chief Executive Officer. “For the millions of patients who still struggle with cardiometabolic disease despite the availability of the newest agents, clofutriben offers a fundamentally different treatment approach by specifically targeting a common but, until now, largely overlooked driver of disease progression and treatment resistance.” Excess cortisol is a well-understood, but underappreciated, driver of metabolic dysfunction across multiple organ systems that causes a spectrum of morbidity including hyperglycemia, hypertension, weight gain, myopathy, dyslipidemia, and osteopenia, as well as mood, memory, and sleep disturbances. By inhibiting HSD-1, clofutriben reduces cortisol production at the intracellular level in key metabolic tissues such as liver, fat, pancreas, muscle, bone, and brain, a novel treatment mechanism complimentary to current therapies approved for cardiometabolic diseases. In previous phase 2 clinical trials, clofutriben improved glycemic control in patients with T2D, including in individuals with both T2D and elevated cortisol due to ACTH-dependent Cushing’s syndrome, with a favorable safety and tolerability profile. The compound requires no dose titration and has shown no evidence of causing adrenal insufficiency. In addition to glycemic improvements, clofutriben has shown evidence for benefits in individual patients across multiple related metabolic parameters, including body weight and composition, lipids, blood pressure, and bone metabolism markers, as well as sleep and quality of life. Approximately half of patients suffering from T2D today are not adequately controlled 1,2 . Up to half of patients with difficult-to-control T2D have an EC level associated with increased comorbidities contributing to cardiometabolic risk 3 . Recent research has demonstrated both that these patients can be easily identified with a simple, inexpensive, and widely available test, and that a cortisol directed agent can improve glycemic control when polypharmacy with current agents has failed 4 . “The CAPTAIN-T2D trial represents a precision approach to a large and well-defined patient population with high unmet needs. Clofutriben’s mechanism targets an underlying contributor to glycemic control challenges that current therapies don’t address,” said Frank Czerwiec, M.D., Ph.D., Chief Medical Officer of Sparrow. “We’re encouraged by the clinical evidence to date and look forward to further evaluating clofutriben’s potential to improve outcomes across multiple metabolic parameters.” About CAPTAIN-T2D CAPTAIN-T2D is a double-blind, Phase 2b trial evaluating clofutriben, a selective inhibitor of 11β-hydroxysteroid dehydrogenase type-1 (HSD-1), to improve glycemic control and metabolic health in patients who have difficult-to-control type 2 diabetes (T2D) with elevated cortisol (EC). The trial will take place in two parts. Part 1 (Screening) will evaluate patients with T2D and EC risk factors for trial eligibility and the presence of EC. Participants deemed eligible from Part 1 will be randomized to either clofutriben or placebo in the dose-ranging, interventional Part 2 (Treatment). The primary endpoint is change in hemoglobin A1c (HbA1c) at 24 weeks. Exploratory endpoints include changes in body weight, blood pressure, cholesterol, and bone metabolism biomarkers. About Sparrow Pharmaceuticals Sparrow Pharmaceuticals is a targeted cardiometabolic therapeutics company delivering breakthrough solutions for the millions of patients who struggle to control prevalent diseases with current therapies. The Company’s lead candidate, clofutriben, is a novel, once-daily, oral HSD-1 inhibitor currently in Phase 2b development for type 2 diabetes with elevated cortisol, a large population with high unmet needs. HSD-1 inhibition is a novel mechanism that complements existing agents by addressing an underlying cause of disease progression and treatment resistance across a spectrum of metabolic dysfunction. Clofutriben has been associated with improved glycemic control and other metabolic improvements while generally safe and well tolerated in multiple clinical trials without requiring dose titration. To learn more, visit or follow us on LinkedIn . Media Contacts Maggie Whitney LifeSci Communications mwhitney@lifescicomms.com ____________________ 1. Center for Disease Control, Type 2 Diabetes, 2024 May 2. Ahmed M, Zulfiqar E, Shafiq A, Shahzad M, Hashmi TM, Ahmed R, Rana JS, Sidney S, Greene SJ, Mentz RJ, Fudim M, Fonarow GC. Type 2 Diabetes Mellitus-Related Mortality in the United States, 1999 to 2023. JACC Adv. 2025 Jul;4(7):101882. doi: 10.1016 3. R J Auchus et al, Characterization of Individuals With Difficult-to-Control Type 2 Diabetes and Post-Dexamethasone Suppression Test Cortisol Values 1.8 µg/dL: Findings From the CATALYST Part 1 Study, JES 2025 4. DeFronzo RA, et al. Diabetes Care. 2025;00(00):1-9. doi:10.2337/dc25-1055