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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.