Research & Development
Phase III LINC 3 Study Demonstrates That Isturisa Improves Physical Features Associated with Hypercortisolism in Patients with Cushing's Disease
13 May 2022 - - A Phase III LINC 3 study demonstrates Isturisa (osilodrostat) improves physical features associated with hypercortisolism in patients with Cushing's disease, Italy-based biopharmaceutical company Recordati Rare Diseases Inc. said.

Isturisa is indicated in the United States for the treatment of adult patients with Cushing's disease.

These findings were presented at the American Association of Clinical Endocrinology annual meeting by Alberto Pedroncelli MD, Head of Clinical Development and Medical Affairs, Global Endocrinology, Recordati AG.

Patients with Cushing's disease experience multiple physical manifestations of hypercortisolism that may reduce quality of life. Improving these physical manifestations is a vital treatment goal for patients with Cushing's disease.

The LINC 3 study demonstrated that Isturisa (osilodrostat) therapy provided long-term mean urinary free cortisol control and clinical improvements, with decreases in patient weight and the severity of physical features, including hirsutism, that were maintained through to week 72.

According to the abstract entitled "Osilodrostat Therapy Improves Physical Features Associated with Hypercortisolism in Patients with Cushing's Disease: Findings from the Phase III LINC 3 Study," 137 adult Cushing's disease patients with mUFC >1.5 x the upper limit of normal were enrolled in the 48-week core phase to evaluate the safety and efficacy of Isturisa in patients with Cushing's disease.

Of these participants, 106 opted to enter the extension phase, which ended when all patients had reached ≥72-week treatment.

This presentation of the concomitant improvements in physical features associated with hypercortisolism follows the publication of the primary endpoint results in Lancet Diabetes and Endocrinology.

The LINC 3 study showed Isturisa rapidly normalized and sustained control of mUFC in most patients with Cushing's disease.

The most common adverse reactions seen in LINC 3 (incidence >20%) were adrenal insufficiency, fatigue, nausea, headache, edema.

All educational content of the AACE annual meeting is planned by its program committee, and AACE does not endorse, promote, approve, or recommend the use of any products, devices or services.

Isturisa (osilodrostat) is a cortisol synthesis inhibitor indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.

Cushing's disease is a form of Cushing's syndrome, in which chronically elevated cortisol levels is triggered by a pituitary adenoma secreting excess adrenocorticotropic hormone.

It is a rare, serious and difficult-to-treat disease that affects approximately one to two patients per m per year.

Prolonged exposure to elevated cortisol levels is associated with considerable morbidity, mortality and impaired QoL as a result of complications and comorbidities.

Normalization of cortisol levels is therefore a primary objective in the treatment of Cushing's disease.

LINC 3 is a prospective, multicentre, 48-week trial with an 8-week, double-blind, randomized withdrawal phase to evaluate the safety and efficacy of ISTURISA in patients with Cushing's disease.

The primary endpoint in the LINC 3 trial is the proportion of patients randomized to ISTURISA and placebo, separately, at Week 26 with a mUFC ≤ULN at the end of the eight-week randomized withdrawal period (Week 34), without a dose increase during this period.

The key secondary endpoint is the proportion of enrolled patients with a mUFC ≤ULN after an initial 24 weeks of open-label treatment with Isturisa without any dose increase after Week 12.

LINC 3 involved 137 patients with persistent or recurrent Cushing's disease despite pituitary surgery or de novo patients for whom surgery was not indicated or who had refused surgery.

Isturisa is a cortisol synthesis inhibitor that works by inhibiting 11-beta-hydroxylase, an enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland. ISTURISA is available as 1 mg, 5 mg and 10 mg film-coated tablets.

Please see prescribing information for detailed recommendations for the use of this product.

In March 2020, the FDA granted marketing authorization for Isturisa in the United States.

Recordati Rare Diseases Inc. is a biopharmaceutical company committed to providing often-overlooked orphan therapies to the underserved rare disease communities of the United States.

Recordati Rare Diseases is a part of the Recordati Group, a public international specialty pharmaceutical company committed to the research and development of new specialties with a focus on treatments for rare diseases.

Recordati Rare Diseases' mission is to reduce the impact of extremely rare and devastating diseases by providing urgently needed therapies.

The company's US corporate headquarters is located in Lebanon, NJ, with global headquarter offices located in Milan, Italy. 
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