US-based biopharmaceutical firm Theravance Biopharma has started a Phase IIb trial of its investigational drug velusetrag (TD-5108) to treat patients with gastroparesis and other gastrointestinal motility disorders.
The multi-centre, double-blind, randomised, placebo-controlled, parallel-group Phase IIb trial is designed to evaluate the efficacy and safety of multiple doses of velusetrag in patients with diabetic or idiopathic gastroparesis.
Gastroparesis is characterised by delayed gastric emptying of food and associated with nausea, vomiting, early satiety, postprandial fullness and upper abdominal pain.
During the trial, three dose levels of velusetrag 5, 15, and 30mg once daily will be evaluated and compared to placebo for 12 weeks of therapy.
The trial's primary endpoint will be the effect of velusetrag on symptoms in subjects with gastroparesis. Initially, the trial will be conducted in the US and will also include some European centres.
It is also designed to evaluate the effect of velusetrag on gastric emptying, and the psychometric properties of the Gastroparesis Rating Scale (GRS), a daily patient-reported outcome (PRO) measure.
Theravance Biopharma Clinical Development senior vice-president Brett Haumann said: "Gastroparesis is a chronic and debilitating condition that causes significant patient suffering, and for which there are few therapeutic options.
"We believe that velusetrag may represent an important approach to treating this disease, which affects close to six million patients in the US alone."
The company is developing velusetrag in collaboration with Alfa Wassermann in a Phase II programme to examine the efficacy, safety and tolerability of velusetrag to treat gastroparesis patients.
The two parties have agreed to advance velusetrag into a definitive Phase IIb trial, based on the positive top-line results from the Phase II proof-of-concept trial.
As part of the deal, majority of the Phase II clinical costs will be paid by Alfa Wassermann, which has an exclusive option to develop and commercialise velusetrag in the EU, Russia, China, Mexico and certain other countries, while the company will retain full rights to velusetrag in the US, Canada, Japan and certain other countries.