A Phase I clinical study to evaluate the safety of Octreolin – an oral therapy for acromegaly patients manufactured by Chiasma – found no serious adverse events among treated subjects.
Acromegaly is a hormonal disorder that results from an excess of growth hormone.
The trial, conducted on 12 healthy volunteers, also showed that Octreolin had a pharmacokinetics profile similar to that of subcutaneously injected octreotide acetate.
Primary objectives of the study were to evaluate the safety, tolerability and PK of the three oral doses of Octreolin in comparison with the subcutaneous injection of octreotide acetate.
Biopharma company Chiasma said it will begin another trial by the end of the year to test the clinical efficacy of Octreolin in acromegaly patients.
The company said it is also developing the drug as a chronic treatment for patients with portal hypertension inhibition to prevent bleeding events and lower mortality rates.