Camurus announced completed enrollment in the randomized, double-blind, placebo-controlled, multicenter Phase 2/3 study, POSITANO, evaluating the efficacy and safety of the company's octreotide subcutaneous depot (CAM2029) in patients with symptomatic polycystic liver disease (PLD). PLD is a rare, genetic, and chronic disorder characterized by progressive growth of cysts in the liver, which can cause severe symptoms and result in impaired quality of life for patients. An estimated 37,000 patients in the US and EU are today living with PLD.

The US Food and Drug Administration (FDA) has granted CAM2029 orphan drug designation for the treatment of PLD. POSITANO enrolled 71 patients diagnosed with PLD who had a height-adjusted liver volume larger than 1,800 mL/m and at least one PLD-related symptom within two weeks of screening. Patients are randomized to one out of two dosing regimens of CAM2029 or to placebo.

The primary endpoint is the change from baseline to week 53 in height-adjusted liver volume and the first secondary endpoint is the change in PLD symptoms measured using a newly developed patient reported outcomes tool, PLD-S. In addition to POSITANO, CAM2029 is in registration phase for the treatment of acromegaly and in an ongoing Phase 3 study, SORENTO, for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NET).