RECORDATI

ISTURISA (OSILODROSTAT) PHASE III LINC-4 TRIAL MEETS ITS PRIMARY ENDPOINT IN CUSHING’S DISEASE

RECORDATI: ISTURISA (OSILODROSTAT) PHASE III LINC-4 TRIAL MEETS ITS PRIMARY ENDPOINT IN CUSHING’S DISEASE

Isturisa (osilodrostat) demonstrates significant and sustained benefit over placebo at normalizing mean urinary free cortisol (mUFC) levels in patients with Cushing’s disease

Milan, 17 June 2020 – Recordati today announces positive results from the large Phase III LINC-4 study of Isturisa (osilodrostat) for the treatment of patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative. Data from the LINC-4 study demonstrate that a significantly higher proportion of patients receiving Isturisa achieve normal mUFC, the primary treatment goal for Cushing’s disease, after 12 weeks of treatment versus placebo (77% vs 8%; P<0.0001). Improvements in mUFC levels are sustained over 36 weeks of treatment (81% of patients). Isturisa is well tolerated and has a manageable safety profile, with the most common adverse events in LINC-4 being arthralgia, decreased appetite, fatigue, and nausea. The findings from LINC-4, the first Phase III study of a medical therapy in Cushing’s disease to contain an upfront placebo-controlled phase, builds on existing clinical evidence and affirms the effectiveness of Isturisa in this hard-to-treat patient population.^1-3

“Cushing’s disease is a chronic and debilitating condition that can be extremely challenging to manage and, if left inadequately treated, can have a significant impact on patients’ quality of life and increase the risk of mortality”, said Richard Feelders, MD, Professor of Endocrinology at the Erasmus University Medical Centre, Rotterdam. “Data from this important Phase III study show that Isturisa (osilodrostat) is an effective and well-tolerated therapy for Cushing’s disease, which significantly reduces and normalizes mUFC levels in most patients. These data are encouraging given the high unmet medical need for patients with this rare disorder”.

“The compelling topline LINC-4 data confirm the effectiveness of Isturisa for the treatment of this rare, potentially life-threatening disease”, stated Andrea Recordati, CEO. “We are deeply grateful to the patients, investigators, clinicians and study staff whose ongoing participation in the clinical development of Isturisa has helped bring this therapy to patients in need.”

Data from the LINC 4 study reinforce the clinical benefits of Isturisa as an effective and generally well‑tolerated oral treatment option for patients with Cushing’s disease. Isturisa has recently received marketing authorization in the European Union (January 2020) and United States (March 2020) for the treatment of Cushing’s syndrome and Cushing’s disease, respectively.