Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of Octreotide Capsules in Patients Who Demonstrated Biochemical Control on Injectable Somatostatin Receptor Ligands (SRL) Treatment

Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated maintenance of biochemical response up to 13 months in the majority of patients with acromegaly previously managed with somatostatin analog injections (reference below).

This is a double blind, randomized study that assesses the efficacy and safety of octreotide capsules vs. placebo. Eligible acromegaly patients, treated with injectable somatostatin analogs, who are biochemically controlled and have prior evidence of active disease, will be randomized to receive either octreotide capsules or placebo for up to 36 weeks. At the end of this double blind, placebo controlled period, eligible patients will receive octreotide capsules in an open-labeled extension for at least one year. Patients failing to respond (per protocol), to oral treatment, (either placebo or octreotide capsules), will be rescued with the standard of care and upon meeting the eligibility criteria could also enroll into the long term extension with octreotide capsules.

This study received agreement from the FDA, under a special protocol assessment.

Inclusion Criteria:

• Documented evidence of active acromegaly
• Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months with a stable dose for at least the last three months of therapy
• Biochemically controlled

Exclusion Criteria:

• Patients taking injections of long-acting Somatostatin Receptor Ligands (SRLs) not as indicated in the label
• Pituitary surgery within six months
• Conventional or stereotactic pituitary radiotherapy any time in the past
• Patients who previously participated in CH-ACM-01 or OOC-ACM-302
• Any clinically significant uncontrolled concomitant disease
• Symptomatic cholelithiasis
• Pegvisomant, within 24 weeks
• Dopamine agonists, within 12 weeks
• Pasireotide, within 24 weeks