Endocrine Abstracts

Background: Octreotide is the most widely used somatostatin analogue; however, the LAR formulation must be reconstituted prior to intramuscular injection. This Phase I study compared the pharmacokinetics and pharmacodynamics of octreotide Fluid Crystal (FC), a ready-to-use depot formulation for s.c. administration, vs octreotide LAR.Methods: After a single dose of octreotide s.c. 200 μg, healthy adult male/female volunteers were randomized 1 week la...

Background: Pasireotide is available in twice-daily subcutaneous (sc) and long-acting intramuscular (im) formulations. Pasireotide sc depot is an investigational extended-release sc formulation designed for improved handling and administration. Results are reported from a Phase I dose-escalating study.Methods: All subjects received a single dose of pasireotide sc (600 μg) and were randomized 12:2:2 to pasireotide sc depot as a single upper-thigh inj...

Background: Somatostatin receptor ligands (SRLs) are first-line standard-of-care therapies for gastroenteropancreatic neuroendocrine tumours (GEP-NETs), showing efficacy in tumour and symptom control with an established safety profile. However, disease progression may occur despite standard-dose SRL treatment, requiring more aggressive and toxic treatments. Retrospective/non-randomized data suggest higher-dose SRLs may benefit patients with GEP-NETs who do not respond to stand...

Background: Octreotide s.c. depot is a novel, ready-to-use formulation administered via a thin needle, which may allow self-administration. In a phase 1 study in healthy volunteers, octreotide s.c. depot provided greater bioavailability with faster onset and greater IGF1 suppression than long-acting octreotide. Here, we present data from a phase 2 study evaluating pharmacokinetics (PK), efficacy, safety, and tolerability of octreotide s.c. depot in patients with acromegaly and...

Acknowledgements: This study was funded by Camurus AB. Medical writing support was provided by Costello Medical and funded by Camurus AB.Background: Somatostatin receptor ligands (SRLs) are first-line standard of care therapies for gastroenteropancreatic neuroendocrine tumors (GEP-NET), showing efficacy in tumor/symptom control with an established safety profile. However, disease progression usually occurs despite standard-dose SRL treatment, requiring m...

Background: Acromegaly is a rare endocrine disorder characterised by excess growth hormone (GH) and insulin-like growth factor 1 (IGF-1) that is associated with significant morbidity and impaired quality of life (QoL). Standard-of-care (SoC) treatments for acromegaly typically require healthcare provider administration, pose a substantial treatment burden, and leave scope for improved disease control. CAM2029, an octreotide subcutaneous depot with ~5x higher bioavailability th...

Background: Acromegaly, a rare, chronic disorder, results from excessive growth hormone (GH) and insulin-like growth factor 1 (IGF-1). The need for convenient therapies that provide effective disease control led to the development of CAM2029, a novel, subcutaneous, octreotide depot designed for convenient monthly self-administration using pre-filled syringes/injection pens. In a 24-week Phase 3 trial (ACROINNOVA 1, NCT04076462) CAM2029 achieved superior IGF-1 control vs placeb...

Background: Acromegaly is a neuroendocrine disorder, characterised by growth hormone (GH) and insulin-like growth factor 1 (IGF-1) overproduction. Persistent biochemical control to minimise adverse effects of prolonged excess GH/IGF-1 is a key treatment goal. CAM2029 is a novel octreotide depot, designed for convenient monthly subcutaneous self-administration, using pre-filled syringes/injection pens. A 24-week Phase 3 trial (ACROINNOVA 1, NCT04076462) evaluated CAM2029 in pat...

Background: Significant treatment-related burdens accompany standard-of-care (SoC) therapies for acromegaly, which typically require healthcare-provider administration. CAM2029 is a novel, subcutaneous octreotide depot conveniently self-administered monthly by pre-filled syringe/injection pen. In a 24-week Phase 3 trial of CAM2029 in patients with acromegaly (ACROINNOVA 1, NCT04076462), insulin-like growth factor 1 (IGF-1) response was 72.2% in patients receiving CAM2029 vs 37...