Camurus reports positive late-stage results for acromegaly treatment

Camurus has announced positive outcomes from a late-phase study of its once-monthly octreotide subcutaneous depot (CAM2029) in patients suffering from acromegaly, a rare disorder characterized by excessive growth hormone production. Acromegaly, which has an estimated prevalence of about 60 cases per million people, leads to abnormal bone and tissue growth, enlarged extremities and facial features, as well as complications like fatigue, joint pain, headaches, vision problems, and excessive sweating.

The 52-week open-label ACROINNOVA 2 study assessed CAM2029 in 135 patients who were either biochemically controlled or uncontrolled on stable doses of standard-of-care (SoC) first-generation somatostatin ligands at the start of the study. This group included 54 patients who were part of the 24-week ACROINNOVA 1 trial. The primary endpoint of the study was safety over the 52-week period, and the results indicated that the drug was well tolerated, with a safety profile consistent with existing SoC treatments.

Significantly, the 52-week treatment led to an increase in treatment response rates by 12.7% in the overall trial population and 22.8% among those new to the study, compared to baseline SoC. Additionally, patients who had controlled IGF-1 levels at baseline maintained or regained biochemical control during treatment with CAM2029. The treatment also showed a “continuous improvement” in acromegaly symptoms and patient-reported outcomes, which included treatment satisfaction and quality of life.

Fredrik Tiberg, President and CEO of Camurus, commented on the findings, emphasizing that the data from ACROINNOVA 2 underscores the long-term safety and efficacy of CAM2029 for acromegaly patients, including those with uncontrolled disease on standard treatment. He noted that the results bolster the case for CAM2029 as a potential new treatment option, pending regulatory approval.

Tiberg also mentioned that regulatory review processes are currently ongoing in both the United States and the European Union, with the U.S. Food and Drug Administration expected to make an initial decision by October 21. Besides its use for acromegaly, CAM2029, which is designed for once-monthly administration using a pre-filled autoinjector pen, is also being developed as a treatment for gastroentero-pancreatic neuroendocrine tumors and polycystic liver disease.