Theravance Biopharma has presented the positive data from a Phase II trial of velusetrag (TD-5108), an investigational drug being developed to treat patients with gastroparesis and other gastrointestinal motility disorders.
According to the company, the trial (study 0093) data demonstrated that all three doses of velusetrag, including 5mg, 15mg and 30mg, decreased gastric emptying time (GE t1/2) compared to placebo in patients with either diabetic or idiopathic gastroparesis.
In the Phase II trial, Theravance enrolled 34 patients with diabetic or idiopathic gastroparesis.
In March this year, the company started a Phase IIb study of velusetrag to treat gastroparesis, based on the positive results from the Phase II trial.
Theravance Biopharma clinical development senior vice-president Dr Brett Haumann said: "Theravance Biopharma is the first company to evaluate a drug candidate for gastroparesis in a broad population that includes both diabetic and idiopathic gastroparetic patients."
The current Phase IIb trial (study 0099) is a multicentre, double-blind, randomised, placebo-controlled and parallel-group study that will assess the efficacy and safety of velusetrag in patients with diabetic or idiopathic gastroparesis.
The study, which is being carried out in the US and Europe, will also assess the effect of velusetrag on gastric emptying and patient-reported outcome (PRO) measures.
Velusetrag is being developed by Theravance in partnership with Alfa Wassermann, which will pay majority of the Phase II clinical costs.
Alfa has been provided an option to develop and commercialise velusetrag in the European Union, Russia, China, Mexico and certain other countries, while Theravance will have full rights in the US, Canada, Japan and certain other countries.