Camurus announces positive Phase 3 results from the ACROINNOVA 2 study of octreotide SC depot (CAM2029) in acromegaly patients
Camurus have announced positive, final, topline results from the 52-week Phase 3 open-label ACROINNOVA 2 study, which evaluated safety and efficacy of the company’s once-monthly octreotide subcutaneous (SC) depot.
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).
“Today’s results from ACROINNOVA 2 highlight the long-term safety profile and efficacy of octreotide SC depot in patients with acromegaly, including patients with uncontrolled disease on standard-of-care", says Fredrik Tiberg, Camurus’ President & CEO, CSO. “These data further strengthen the evidence base for CAM2029 octreotide SC depot as a new treatment option for people living with acromegaly, if approved. Regulatory reviews are ongoing in both the US and EU with a first approval decision expected from the US FDA by the PDUFA action date 21 October 2024.”
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.
“The results from ACROINNOVA 2 are very encouraging and demonstrated that CAM2029 octreotide SC depot was effective in normalizing IGF-1 levels across patient groups and continuously improving symptoms of acromegaly throughout the 52 weeks of treatment. Additionally, the convenience of a once-monthly SC dosing using the prefilled autoinjector pen contributed to improved treatment satisfaction and quality of life, which are important unmet needs for patients living with acromegaly”, says Joanna Spencer-Segal, M.D., Ph.D., Asst. Professor of Internal Medicine, Div. of Metabolism, Endocrinology and Diabetes, University of Michigan, Ann Arbor, Michigan, US, and ACROINNOVA 2 study investigator.
For further information and references, read the original press release here.
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