Chiasma has completed patient enrollment in the Phase ll clinical trial of octreotide capsules for the treatment of Acromegaly Drugs Development Market, the MPOWERED trial.
A sum of 135 acromegaly patients have been signed up for the worldwide, randomized, open-name and dynamic controlled, 15-month preliminary.
After a six-month run-in period, approximately 80 patients who respond to octreotide capsules will be randomly assigned to receive either injectable somatostatin receptor ligands (octreotide or lanreotide) or octreotide capsules. They will then be followed for an additional nine months.
The preliminary is supposed to break down the extent of patients who keep up with their biochemical reaction to octreotide cases and patient-announced results in patients treated with octreotide containers, contrasted with patients treated with standard of care injectable somatostatin receptor ligands.
The MPOWERED trial aims to present final results in the early part of 2020. It is expected to be finished by the fourth quarter of next year.
"As we seek to advance octreotide capsules as a maintenance treatment for adult patients with acromegaly," "we are making significant progress."
The purpose of the trial is to assist Chiasma in obtaining regulatory approval for the octreotide capsule in the European Union.
Mark Fitzpatrick, president and CEO of Chiasma, stated: In our efforts to advance octreotide capsules as a maintenance treatment for adult acromegaly patients, we are making significant progress.
Octreotide capsules, if approved, will offer these patients an oral alternative to injectable somatostatin analogs, which are the current standard of care.
As a potential new oral medication for adult acromegaly patients to use as a maintenance treatment, octreotide capsules are currently the subject of research.
Acromegaly is typically brought on by a benign tumor of the pituitary gland that produces additional growth hormone (GH), which, if left untreated, eventually results in serious health issues and early death.