Swedish biopharmaceutical company Camurus AB (STO:CAMX) on Monday announced positive topline results from the 52-week Phase 3 open-label ACROINNOVA 2 study evaluating the safety and efficacy of its once-monthly octreotide subcutaneous (SC) depot (CAM2029) in acromegaly patients.

The study included 135 patients with acromegaly, of which 81 were new patients and 54 were roll-over patients from the ACROINNOVA 1 study. The primary endpoint was safety, and octreotide SC depot was well tolerated with no new safety signals.

Significant increases were seen in treatment response rates compared to standard-of-care (SoC) at baseline, with a 12.7% increase in the overall population and a 22.8% increase in new patients. Roll-over patients maintained or regained biochemical control during treatment with octreotide SC depot.

Treatment with octreotide SC depot also resulted in continuous improvement of acromegaly symptom scores and patient-reported outcomes compared to SoC at baseline. Regulatory reviews are ongoing in the United States and European Union, with a first approval decision expected from the US FDA by the PDUFA action date of 21 October 2024.