Camurus announced positive, final, topline results from the 52-week Phase 3 open-label Acroinnova 2 (NCT04125836) study, which evaluated safety and efficacy of the company's once-monthly octreotide subcutaneous (SC) depot (CAM2029). The study included a total of 135 patients with acromegaly who were biochemically controlled (IGF-1=1xULN) or uncontrolled on stable doses of standard-of-care (SoC) with first generation somatostatin ligands (SRL) at screening; of these, 81 were new to study patients and 54 were roll-over patients from 24-week randomized treatment with octreotide SC depot or placebo (Acroinnova 1). The primary endpoint was safety over 52 weeks of study treatment.

Octreotide SC depot was well tolerated with a long-term safety profile consistent with that of SoC with first generation somatostatin receptor ligands (SRL), extended-release octreotide and lanreotide, with no new safety signals. The most common adverse events (AEs) were mild to moderate injection site reactions and gastrointestinal events. There were no cases of severe AEs related to octreotide SC depot.

One patient had a treatment-related serious adverse event of cholelithiasis (moderate), which resolved, and the patient continued treatment in the trial. Two patients (1.5%) discontinued treatment due to AEs; one case of mild depression and once case of mild injection site hemorrhage. Acroinnova 2 included multiple secondary endpoints, including biochemical control rates, symptom scores, and several patient-reported outcomes.

Treatment with octreotide SC depot over 52 weeks resulted in significant increases in treatment response rates of 12.7% (95%CI: 5.5%, 19.9%) in the overall population, and 22.8% (95%CI: 11.6, 33.9) in new patients compared SoC at baseline. Roll-over patients, with controlled IGF-1 values at the SoC baseline, maintained or regained (for placebo) 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, including treatment satisfaction, acromegaly quality of life, and self-injection assessment scores compared to SoC at baseline.