Swedish pharmaceutical and biotechnology company Camurus (STO:CAMX) on Tuesday reported topline results from the 12-month, randomised, double-blind, placebo-controlled POSITANO Phase 2b study, evaluating efficacy and safety of octreotide subcutaneous (SC) depot (CAM2029) in patients with symptomatic polycystic liver disease (PLD).

POSITANO enrolled 71 participants with symptomatic PLD randomised to treatment with one out of two dosing regimens of CAM2029 or placebo in a 1:1:1 ratio. According to the company, the study met the primary endpoint showing a statistically significant relative reduction of the height-adjusted liver volume (htTLV) from baseline to week 53 of 4.3% (p=0.044) for the combined CAM2029 groups compared to placebo.

The corresponding relative reduction in total liver cyst volume was 8.7% (p=0.016). Treatment with CAM2029 also resulted in improvements in disease symptoms and other patient and clinical reported outcomes.

CAM2029 was well tolerated with a safety profile consistent with the established safety profile of approved injectable somatostatin receptor ligands, octreotide and lanreotide. No new or unexpected safety findings were noted. Detailed results from the POSITANO study will be presented at future scientific meetings and in publications.

Camurus says that after completion of the randomised part of POSITANO, the treatment of patients continues with CAM2029 in a 2.5-year, open extension phase of the study where further long-term efficacy and safety data are being collected. CAM2029 has been granted Orphan Drug Designation for the treatment of autosomal dominant PLD in the United States and the European Union.