Biotechnology firm Ascendis Pharma has revealed the positive top-line results from its six-month Phase II paediatric trial of once-weekly TransCon Growth Hormone.

The study has been designed to assess the safety and efficacy of the TransCon Growth Hormone in 53 treatment-naïve and pre-pubertal children to treat growth hormone deficiency (GHD).

The Phase II paediatric study coordinating investigator Dr Pierre Chatelain said: “I am highly encouraged by the mean annualized height velocity achieved by once-weekly TransCon Growth Hormone in the Phase II paediatric study.

“Based on these top-line data, once-weekly TransCon Growth Hormone appears comparable to gold-standard daily growth hormone therapies in terms of efficacy, safety and tolerability, with reduced injection frequency that may allow for improved patient compliance and treatment outcomes.”

“I am highly encouraged by the mean annualized height velocity achieved by once-weekly TransCon Growth Hormone.”

The trial evaluated the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of the TransCon Growth Hormone in treatment-naïve pre-pubertal children with GHD.

The firm enrolled 53 patients in the treatment phase of the trial, which was a six-month multi-center, randomised and open-label study that compared three dose levels of TransCon Growth Hormone against the active control Genotropin.

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.

Three dose levels of TransCon Growth Hormone, including 0.14, 0.21, and 0.30mg hGH / kg / week, were administered once per week, while the active control Genotropin with 0.21 mg hGH / kg / week was administered as a daily injection.

In the trial, mean annualised height velocities among the three dosing levels administered weekly ranged from 11.9cm for the 0.14 mg/kg/week dose to 13.9cm for the 0.30mg / kg / week dose, which were comparable to 11.6cm for the active comparator, daily injections of Genotropin at a 0.21mg / kg / week dose, said the company.