SUN-045 Improved Patient-Reported Outcomes with CAM2029 Treatment, an Octreotide Subcutaneous Depot, in Patients with Acromegaly Previously on Standard-of-Care Injectable Somatostatin Receptor Ligands: Final Analysis of the Core Part of the ACROINNOV

Abstract Disclosure: D. Ferone: Principal investigator at trial site; received trial support from Camurus AB. Consultant for and research grants received from Camurus AB, Ipsen, Novartis-AAA, and Recordati. B. Biller: Principal investigator of institutional research grants from Crinetics Pharmaceuticals; recipient of occasional consulting honoraria from Amolyt Pharma, Camurus AB, Chiesi Farmaceutici S.p.A, Crinetics Pharmaceuticals, Pfizer and Recordati. M.R. Gadelha: Recipient of speaker fees from Recordati, Ipsen, Novo Nordisk A/S and Camurus AB; attended advisory boards for Novo Nordisk A/S, Recordati and Crinetics Pharmaceuticals. J.M. Silverstein: Principal investigator at trial site; received trial support from Camurus AB; funding to institution from Fractyl Health, Amryt Pharma/Chiasma Pharmaceuticals/Chiesi Farmaceutici S.p.A, Ascendis Pharma, Bayer AG, Sparrow Pharmaceuticals, Recordati, AbbVie, Corcept Therapeutics and Cortendo AB; occasional consultant for Xeris Biopharma and Camurus AB. P. Kadioglu: Principal investigator at trial site; received trial support from Camurus AB. J. Seufert: Principal investigator at trial site; received trial support from Camurus AB. M. Fleseriu: Recipient of institutional grants from Crinetics Pharmaceuticals and occasional scientific consulting honoraria from Amolyt Pharma, Camurus AB, Crinetics Pharmaceuticals, Debiopharm, Novo Nordisk A/S, and Recordati. A.M. Pedroncelli: Employee and shareholder of Camurus AB. J. Råstam: Employee and shareholder of Camurus AB. M. Harrie: Employee and shareholder of Camurus AB. A. Svedberg: Employee and shareholder of Camurus AB. F. Tiberg: Employee and shareholder of Camurus AB. J.L. Spencer-Segal: Principal investigator at trial site; received trial support from Camurus AB; advisor to Camurus AB and Crinetics Pharmaceuticals. Background: Standard-of-care somatostatin receptor ligand therapies (SoC; octreotide long-acting repeatable/lanreotide Autogel) for acromegaly require in-office administration and can be burdensome. CAM2029, a long-acting, octreotide subcutaneous depot developed using FluidCrystal® technology, is conveniently self-administered via autoinjector pen. In the 24-week (W), Phase 3 ACROINNOVA 1 trial (NCT04076462), CAM2029 achieved superior biochemical control vs placebo (PBO) and improved quality of life (QoL) vs SoC in patients previously biochemically controlled. ACROINNOVA 2 (NCT04125836) assessed long-term safety and efficacy, including patient-reported outcomes (PROs). Methods: ACROINNOVA 2, a 52-W, Phase 3, open-label trial (with 52-W extension), enrolled patients with insulin-like growth factor I ≤2×upper limit of normal on SoC, and patients completing ACROINNOVA 1 (prior-CAM2029; prior-PBO). Patients received CAM2029 20 mg every 4 W (±1 W) for the core 52 W (prior-PBO, W24−52). The primary endpoint was safety (not reported). PRO-related secondary endpoints included: Acromegaly QoL Questionnaire (AcroQoL); Treatment Satisfaction Questionnaire for Medication (TSQM); proportion of patients/partners who opted to administer CAM2029; and the Self-Injection Assessment Questionnaire (SIAQ v2.0). Higher scores reflect improvements. Data shown are for the overall core phase population. Results: ACROINNOVA 2 enrolled 135 patients: 81 patients directly and 54 roll-over patients from ACROINNOVA 1 (prior-CAM2029, n=36; prior-PBO, n=18); 127 patients completed treatment (directly enrolled, n=74; roll-over, n=53). CAM2029 was well tolerated; no new safety signals were identified. PRO scores progressively improved from SoC baseline to W52; results indicated a further improvement from W24 to 52. Scores that increased from SoC baseline to W52 included mean AcroQoL total score (range 0−100) by 3.0 (95% confidence intervals [CI]: 1.0, 5.0) and mean TSQM (range 0−100): ‘convenience’ by 15.4 (95% CI: 12.0, 18.8); ‘effectiveness’ by 5.4 (95% CI: 2.1, 8.8); and ‘global satisfaction’ by 4.0 (95% CI: 0.8, 7.2). Most (91.1% [123/135]) patients/partners opted to self-administer. Mean SIAQ scores (range 0−10) increased from pre-treatment to last measurement (W48) for: ‘satisfaction with way of taking medication’ by 1.6 (95% CI: 1.1, 2.1); ‘self-confidence’ by 0.9 (95% CI: 0.4, 1.4); ‘feelings about injections’ by 0.8 (95% CI: 0.4, 1.3). Conclusions: CAM2029 showed a long-term safety profile similar to SoC. Patients experienced continuous improvements in QoL and treatment satisfaction scores with long-term CAM2029 treatment vs SoC baseline. Patients/partners were confident about self-administration and highly satisfied with their experience. CAM2029 has the potential to enhance QoL and treatment satisfaction, both important unmet needs in patients with acromegaly. Presentation: Sunday, July 13, 2025