Octreotide CAM2029 Returns Positive Results for the Treatment of Acromegaly in ACROINNOVA 2 Phase III Study

Image Credit: © jarun011 - stock.adobe.com

Camurus has shared positive, final, topline results from the ACROINNOVA 2 Phase III clinical trial (NCT04125836). The study evaluated the safety and efficacy of Camurus’ once-monthly octreotide subcutaneous (SC) depot, CAM2029 in patients with acromegaly.¹

Overall, results from the trial indicated that treatment was well tolerated with a safety profile consistent with standard-of-care (SoC), increased biochemical response rates (IGF-1≤1xULN) vs SoC at baseline, and continuous improvement of acromegaly symptom and quality of life scores vs baseline.

The open-label, single-arm, multi-center Phase III trial spanned 52 weeks and included a total of 135 patients with acromegaly who were biochemically controlled (IGF-1≤1xULN) or uncontrolled on stable doses of SoC with first generation somatostatin ligands (SRL) at screening. Of these participants, 81 were new to the study and 54 were roll-over from a 24-week randomized treatment with octreotide SC depot or placebo (ACROINNOVA 1). The primary endpoint was safety over 52 weeks of study treatment with secondary endpoints including biochemical control rates, symptom scores, and several patient-reported outcomes.²

Acromegaly is a hormonal disorder that develops when the pituitary gland produces too much growth hormone during adulthood. This leads to an increase in bone size of the hands, feet, and face. Since the disorder is uncommon and physical changes occur slowly, it often takes a long time to recognize.³

“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", Fredrik Tiberg, Camurus’ president & CEO, CSO said in a press release. “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 October 21, 2024.”

According to Camurus, octreotide SC depot was well tolerated with a long-term safety profile consistent with that of SoC with first generation SRL, extended-release octreotide and lanreotide, with no new safety signals. Treatment with octreotide SC depot over the 52-week study timeline 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. Additionally, 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.

In the press release, Joanna Spencer-Segal, MD, PhD, assistant professor of internal medicine, division of Metabolism, endocrinology and diabetes, University of Michigan, Ann Arbor, Michigan, US, and ACROINNOVA 2 study investigator added: “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.”

References

1. Camurus announces positive Phase 3 results from the ACROINNOVA 2 study of octreotide SC depot (CAM2029) in acromegaly patients. News release. Camurus. July 15, 2024. Accessed July 16, 2024. https://www.camurus.com/media/press-releases/2024/camurus-announces-positive-phase-3-results-from-the-acroinnova-2-study-of-octreotide-sc-depot-cam2029-in-acromegaly-patients

2. A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly. ClinicalTrials.gov. Accessed July 16, 2024. https://clinicaltrials.gov/study/NCT04125836?tab=history&a=4

3. Acromegaly. Mayo Clinic. February 8, 2024. Accessed July 16, 2024. https://www.mayoclinic.org/diseases-conditions/acromegaly/symptoms-causes/syc-20351222#:~:text=Acromegaly%20is%20a%20hormonal%20disorder,in%20height%20doesn't%20occur.