PIPELINE & PROGRAMS
Sparrow is developing clofutriben, a novel HSD-1 inhibitor, to address unmet needs in type 2 diabetes.
Diabetes remains a global epidemic.
In the US and EU alone, it is projected that 60 million people will have diabetes by 2035. Despite the availability of recent advances such as GLP-1 agonists and SGLT2 inhibitors, nearly half of patients with type 2 diabetes (T2D) today remain inadequately controlled.
Almost 50% of patients with difficult-to-control diabetes display increased cardiometabolic risk associated with elevated cortisol.
Excess cortisol can drive disease progression and render T2D resistant to available antidiabetic medications including injected insulin. Elevated cortisol can be caused by a tumor that either directly or indirectly causes excess adrenal production or by HPA-axis dysregulation from chronic stress. Chronic stress can be caused by poorly controlled disease including type 2 diabetes itself.
Targeting cortisol in patients with difficult-to-control T2D and elevated cortisol may enable improved glycemic control when currently available therapies have proven inadequate.
Our targeted agent clofutriben is being developed to improve glycemic control and metabolic health in patients with type 2 diabetes and elevated cortisol.
About clofutriben
Clofutriben, a once-daily, oral, highly potent and selective inhibitor of 11β-hydroxysteroid dehydrogenase type 1 (HSD-1), is in development for the treatment of patients who have type 2 diabetes (T2D) with elevated cortisol (EC). In eight prior clinical trials, clofutriben has been found to be generally safe with no evidence of adrenal insufficiency, has demonstrated a favorable tolerability profile, and has not required dose titration.
Efficacy data from prior trials in patients with painful diabetic peripheral neuropathy and endogenous Cushing’s syndrome (a rare disease of severely elevated cortisol) provide promising evidence that clofutriben could enable better glucose control in patients with T2D and elevated cortisol.
Potential Benefits:
High Efficacy
Two previous clinical trials demonstrated the potential for improved glucose control, including in patients with elevated cortisol.
Strong Safety
In eight previous clinical trials, clofutriben demonstrated favorable safety and tolerability with no evidence of adrenal insufficiency.
High Adherence
Clofutriben is an oral, small molecule that is administered as one tablet once-daily.
No Titration
The risk of adrenal insufficiency with HSD-1 inhibition is expected to be low, alleviating the need for careful titration and complex monitoring.
About CAPTAIN-T2D, a Phase 2b clinical trial
CAPTAIN-T2D is a double-blind, randomized, placebo-controlled, dose-ranging 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 treatment-resistant type 2 diabetes (T2D) with elevated cortisol (EC).
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.