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Mario Maldonado, MD, Global Head of Clinical Development for Endocrinology at Recordati Rare Diseases, discusses Recordati’s presentations at ENDO 2025.


LINC6 Clinical Trial

LINC 6 is an ongoing, prospective observational study evaluating the long-term safety and efficacy of osilodrostat over 3 years in 205 adult patients with Cushing’s disease (CD) and non-pituitary Cushing’s syndrome (non-PCS). Osilodrostat is a potent 11β-hydroxylase inhibitor. Results were presented from a 2 year interim analysis.

Treatment-related adverse events were reported 91 times in 34 patients with CD and 14 times in 9 patients with non-PCS, most being mild to moderate. The most common treatment-related adverse events in patients with CD were adrenal insufficiency, diarrhea, dizziness, fatigue, and nausea. In patients with non-PCS the most common adverse events were adrenal insufficiency, hypokalemia, abnormal hormone cortisol level, dizziness, hirsutism, joint stiffness, musculoskeletal stiffness, and nervous system disorder.

A total of 17 patients with CD reported 29 serious adverse events, while 10 patients with non-PCS reported 16 serious adverse events. Patients with CD and non-PCS reported 21 and 9 hypocortisolism-related adverse events, 16 and 6 adrenal hormone precursor accumulation-related adverse events, and 3 and 0 arrhythmogenic potential/QT interval prolongation-related adverse events, respectively. Patients with CD had 3 pituitary tumor enlargement-related adverse events. At month 3, mUFC and LNSC were normal in 73.9% and 56.3% of pts. By month 6, mUFC and LNSC were normal in 63.0% and 30.4% of pts.


Osilodrostat Rollover Study

The LINC rollover study was an open-label, multicenter trial evaluating long-term safety and efficacy of osilodrostat in patients with CD. A total of 127 participants were included after completing either the LINC 2, LINC 3, or LINC 4 clinical trial extension phase.

All patients experienced at least one adverse event, with 86.6% considered treatment related. The most common adverse events were nausea, adrenal insufficiency, and fatigue. Serious adverse events were reported in 44.9% of participants, with 8.7% considered treatment related. The most common serious adverse event was adrenal insufficiency. Additionally, adverse events related to accumulation of adrenal hormone precursors were reported in 65.4%, hypocortisolism in 55.9%, pituitary tumor enlargement in 8.7%, and arrhythmogenic potential and QT prolongation in 5.5%.

At the end of treatment, 78% continued to receive clinical benefit. From baseline to week 12 of the parent studies, mean urinary free cortisol levels decreased from 561.5 nmol/24 h to 85.0 nmol/24 h, mean glycated hemoglobin levels decreased from 5.8% to 5.6%, mean systolic blood pressure decreased from 130.7 mmHg to 123.2 mmHg, body weight generally decreased over time, and potassium and sodium levels remained stable and normal.

Chapters:
Introduction 00:00
Recordati Overview 00:19
Poster Presentations 1:25
Recordati's Future 7:28