SUN-097 CAM2029 Octreotide Subcutaneous Depot Maintains Control of IGF-I and Symptoms of Acromegaly Across the 4-Week Dosing Interval and During Intervals Greater Than 28 Days: Data from the ACROINNOVA 1 Trial

Abstract Disclosure: Background: Acromegaly is characterized by excess growth hormone and insulin-like growth factor-I (IGF-I). Medical therapies aim to achieve biochemical and symptom control. However, some patients report the emergence of symptoms toward the end of dosing intervals with standard-of-care (SoC) injectable somatostatin receptor ligands, possibly indicating waning biochemical control. CAM2029 is a novel, subcutaneous octreotide depot designed for self-administration by injection; the extended-release, long-acting formula uses FluidCrystal® technology. In the 24-week, Phase 3 ACROINNOVA 1 trial (NCT04076462), CAM2029 demonstrated superior IGF-I control (IGF-I ≤ upper limit of normal [ULN]) versus placebo (72.2% vs 37.5%; P=0.0018) in patients who had been controlled with SoC at screening. We now report further analyses, assessing IGF-I and symptom control at multiple timepoints over a 4-week interval following the final CAM2029 dose. Additionally, these data are presented for patients with delayed visits, reflecting extended dosing intervals. Methods: Patients randomized to the CAM2029 group received CAM2029 20 mg every 4 weeks (±1 week) for a 24-week treatment phase. The final dose was received at week (W) 20, and the end of trial (EOT) was scheduled for W24. IGF-I levels and Acromegaly Index of Severity (AIS; evaluation of key acromegaly symptoms by clinician and patient together) were assessed at W20 pre-CAM2029 administration, W22 and W24/EOT (interval ≤28 days). Some patients experienced a delay in their planned W24/EOT visits, resulting in extended dose-to-assessment visit intervals (>28 days). Results: Forty-eight patients were randomized to CAM2029. Of the 42 patients (87.5%) completing treatment, 45.2% (19/42) had the planned W24/EOT assessment ≤28 days from their W20 CAM2029 dose. Of these, the majority (15/19 [78.9%]) achieved IGF-I/ULN ≤1 at W24/EOT; mean IGF-I/ULN values remained stable across W20 (0.83), W22 (0.77) and W24/EOT (0.80). Mean AIS overall scores were stable from W20 (4.7) to W22 (4.2) and W24/EOT (3.6). 54.8% (23/42) of patients had a dose-to-W24/EOT assessment interval of >28 days (maximum interval 42 days; mean 33.4 days). IGF-I/ULN ≤1 was achieved in 78.3% (18/23) of these patients at the W24/EOT visit, despite the delay between CAM2029 dose and assessment; mean IGF-I/ULN values were stable across the extended interval (0.81, 0.84 and 0.78 at W20, W22 and W24/EOT, respectively). Similarly, over intervals of >28 days, CAM2029 maintained stable mean AIS overall scores across W20 (4.3), W22 (4.3) and W24/EOT (4.7) assessments. Conclusions: CAM2029 effectively maintained stable biochemical and symptom control both throughout the intended 4-week dosing interval and with extended dosing intervals. These data inform on the efficacy profile of CAM2029 when administration occurs both within and beyond a 28-day dosing window. Presentation: Sunday, July 13, 2025