CAm<SUP>2</SUP>029 octreotide subcutaneous depot provides stable control of IGF-I and improves key symptoms throughout a 4-week post-dose interval: analysis from the ACROINNOVA 1 trial

Gadelha Monica R.; Biller Beverly M.K.; Maria Fleseriu; Spencer-Segal Joanna L.; Silverstein Julie M.; Irina Bancos; Jacob Rastam; Pedroncelli Alberto M.; Fredrik Tiberg; Diego Ferone

doi:10.1530/endoabs.110.P945

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Endocrine Abstracts (2025) 110 P945 | DOI: 10.1530/endoabs.110.P945

ECEESPE2025 Poster Presentations Pituitary, Neuroendocrinology and Puberty (162 abstracts)

CAm²029 octreotide subcutaneous depot provides stable control of IGF-I and improves key symptoms throughout a 4-week post-dose interval: analysis from the ACROINNOVA 1 trial

Monica R. Gadelha ¹ , Beverly M.K. Biller ² , Maria Fleseriu ³ , Joanna L. Spencer-Segal ⁴ , Julie M. Silverstein ⁵ , Irina Bancos ⁶ , Jacob Råstam ⁷ , Alberto M. Pedroncelli ⁷ , Fredrik Tiberg ⁷ & Diego Ferone ⁸

Author affiliations

¹Neuroendocrinology Research Center/Endocrinology Division, Medical School and Hospital Universitario Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil; ²Neuroendocrine and Pituitary Tumor Clinical Center, Massachusetts General Hospital, Boston, MA, United States; ³Pituitary Center, Departments of Medicine and Neurological Surgery, Oregon Health and Science University, Portland, OR, United States; ⁴Department of Internal Medicine and Michigan Neuroscience Institute, University of Michigan, Ann Arbor, MI, United States; ⁵Division of Endocrinology, Metabolism and Lipid Research, Department of Neurosurgery, Washington University School of Medicine, St. Louis, MO, United States; ⁶Division of Endocrinology, Mayo Clinic, Rochester, MN, United States; ⁷Camurus AB, Lund, Sweden; ⁸Endocrinology Unit, Department of Internal Medicine, IRCCS Ospedale Policlinico San Martino, Genova, Italy

JOINT1738

Background: Standard-of-care medical therapies (injectable somatostatin receptor ligands) aim to control the excess insulin-like growth factor-I (IGF-I) levels characteristic of acromegaly. Symptom control is also key. However, increased symptoms towards the end of dosing intervals are reported by some patients, possibly indicating waning biochemical control. Designed for self-administration by injection, CAm²029 is a novel subcutaneous octreotide depot with a prolonged-release, long-acting formula developed using FluidCrystal^® technology. The efficacy of CAm²029 was evaluated in ACROINNOVA 1, a 24-week, Phase 3 trial (NCT04076462). Superior IGF-I control (IGF-I ≤upper limit of normal [ULN]) vs placebo (72.2% vs 37.5%; P=0.0018) and symptom control were demonstrated in patients previously controlled. We report further analyses in patients receiving CAm²029, evaluating IGF-I and symptom control over a 4-week interval from administration of the final CAm²029 dose.

Methods: Over a 24-week treatment phase, patients randomised to CAm²029 received 20 mg every 4 weeks (±1 week); the final dose was administered at week (W) 20. Assessments of IGF-I levels and symptom severity (via the Acromegaly Index of Severity [AIS]; JOINT clinician and patient evaluation of key symptoms) took place at least every 4 weeks throughout the treatment phase, including at W20 prior to CAm²029 administration, W22 and W24/end of trial (EOT).

Results: Forty-eight patients were randomised to CAM2029 and 42 (87.5%) completed treatment. Mean IGF-I/ULN values remained stable over W20, W22 and W24/EOT (0.82, 0.81 and 0.79, respectively). A slight reduction (improvement) in mean AIS overall scores was observed from W20 (4.5) to W22 (4.3) and W24/EOT (4.2). The proportions of patients affected by symptoms of acromegaly across the dose-to-assessment interval are shown in the Table.

Table Patients with symptoms of acromegaly.
Symptom	W20*	W22	W24/EOT
		n/N_all ^† (%)
Fatigue	30/42 (71.4)	28/41 (68.3)	28/42 (66.7)
Headache	19/42 (45.2)	16/41 (39.0)	13/42 (31.0)
JOINT pain	30/42 (71.4)	27/41 (65.9)	34/42 (81.0)
Paraesthesia	14/42 (33.3)	12/41 (29.3)	13/42 (31.0)
Soft tissue swelling	16/42 (38.1)	13/41 (31.7)	13/42 (31.0)
Sweating	19/42 (45.2)	21/41 (51.2)	21/42 (50.0)
*Prior to final CAm²029 administration; ^†Patients completing treatment with CAm²029 and attending assessment.

Conclusions: Patients established on CAM2029 maintained stable control of IGF-I at all timepoints across the 4 weeks, post-dose. Symptoms were also well controlled throughout the dosing interval, with patients experiencing improvements in some key symptoms such as headache and fatigue. These data indicate that CAm²029 continuously and consistently reduces the burden of disease for patients across the 4-week dosing interval.