Camurus has shared positive results from a late-stage study of its once-monthly octreotide subcutaneous depot (CAM2029) in patients with acromegaly, a rare and progressive disease in which the body produces too much growth hormone.
With an estimated prevalence of approximately 60 cases per million, acromegaly can result in the abnormal growth of bone and tissue, enlarged hands, feet, facial features and inner organs, as well as symptoms such as fatigue, joint pain, headaches, visual field defects and excessive sweating.
The 52-week open-label ACROINNOVA 2 study has been evaluating Camurus’ candidate in 135 patients who were biochemically controlled or uncontrolled on stable doses of standard-of-care (SoC) with first-generation somatostatin ligands at screening, 54 of whom were roll-over patients from the 24-week ACROINNOVA 1 trial.
The study met its primary endpoint of safety over 52 weeks, with the drug found to be well tolerated with a long-term safety profile consistent with that of SoC.
The treatment over 52 weeks resulted in increases in treatment response rates of 12.7% in the overall trial population and 22.8% in those who were new to the study compared to SoC at baseline.
Roll-over patients with controlled IGF-1 values at the SoC baseline maintained or regained biochemical control during treatment with the drug, Camurus said, adding that the treatment also resulted in “continuous improvement” of acromegaly symptom scores and patient reported outcomes, including treatment satisfaction and quality of life.
Fredrik Tiberg, Camurus’ president and chief executive officer, said: “[The] results from ACROINNOVA 2 highlight the long-term safety profile and efficacy of [CAM2029] in patients with acromegaly, including patients with uncontrolled disease on SoC.
“This data further strengthens the evidence base for CAM2029 as a new treatment option for people living with acromegaly, if approved.”
Tiberg added that regulatory reviews are “ongoing” in both the US and EU, with a first approval decision expected from the US Food and Drug Administration by 21 October.
CAM2029, designed for once-monthly administration with a pre-filled autoinjector pen, is also under development to treat gastroentero-pancreatic neuroendocrine tumours and polycystic liver disease.