Chiasma has completed patient enrolment in the MPOWERED trial, a Phase lll clinical study of octreotide capsules to treat patients with acromegaly.
A total of 135 acromegaly patients have been enrolled in the global, randomised, open-label and active-controlled, 15-month trial.
Approximately 80 patients who respond to octreotide capsules after a six-month run-in period will be randomised to receive either octreotide capsules or injectable somatostatin receptor ligands (octreotide or lanreotide), and then followed for an additional nine months.
The trial is expected to analyse the proportion of patients who maintain their biochemical response to octreotide capsules and patient-reported outcomes in patients treated with octreotide capsules, compared to patients treated with standard of care injectable somatostatin receptor ligands.
Scheduled to be completed by the last quarter of next year, the MPOWERED trial aims to provide top-line results in early 2020.
The trial is set to support Chiasma to obtain regulatory approval in European Union for the octreotide capsule.
Chiasma president and CEO Mark Fitzpatrick said: “We are making significant progress as we seek to advance octreotide capsules as a maintenance treatment for adult patients with acromegaly.
“If approved, octreotide capsules will provide these patients with an oral alternative to the current standard of care, injectable somatostatin analogs.”
Octreotide capsules are currently being investigated as a new oral drug for use as a maintenance therapy of adult patients with acromegaly.
Acromegaly is commonly caused by a benign tumour of the pituitary gland that produces an additional growth hormone (GH), thereby eventually leading to significant health problems and early death if untreated.