Salute e Benessere
Camurus' POSITANO study shows treatment effects with CAM2029 in polycystic liver disease patients
"The POSITANO study shows that CAM2029 significantly reduces liver and liver cyst volume compared to placebo while showing improvements in symptoms as assessed by relevant patient reported outcomes", says Dr Joost P.H. Drenth , Professor of Hepatology, Amsterdam University Medical Center and coordinating investigator for the POSITANO study. "There is a high unmet medical need for treatment of patients with polycystic liver disease and the POSITANO study brings hope for our patients."
POSITANO enrolled 71 participants with symptomatic PLD randomized to treatment with one out of two dosing regimens of CAM2029 or placebo in a 1:1:1 ratio. 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.
"The POSITANO study met the primary endpoint showing that CAM2029 reduces liver and cyst growth and can improve disease symptoms and other outcomes in patients with polycystic liver disease", says Fredrik Tiberg , Camurus' President & CEO, CSO. "Based on the results, Camurus intends to discuss the design of a confirmatory Phase 3 study with regulatory authorities in the US and Europe ."
CAM2029 was well tolerated with a safety profile consistent with the established safety profile of approved injectable somatostatin receptor ligands, octreotide and lanreotide. The most frequently reported adverse effects were diarrhea, and mild to moderate gastrointestinal disturbances and injection site reactions. No new or unexpected safety findings were noted. Detailed results from the POSITANO study will be presented at future scientific meetings and in publications.
After completion of the randomized 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 (ODD) for the treatment of autosomal dominant PLD in the US by the U.S. Food and Drug Administration (FDA) and in the EU by the European Commission.
Fredrik Tiberg , President & CEO
Tel. +46 (0)46 286 46 92
fredrik.tiberg@camurus.com
Fredrik Joabsson, Chief Business Development Officer
Tel. +46 (0)70 776 17 37
ir@camurus.com
This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the managing director, at 8:00 am CET on 18 June 2025 .
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