Market Overview

PROLOR Biotech Commences Phase III Trial of Longer-Acting Version of HGH

Share:

PROLOR Biotech, Inc. (NYSE: PBTH), a company developing next-generation biobetter therapeutic proteins, today announced the initiation of a pivotal Phase III clinical trial of hGH-CTP, the company's proprietary version of human growth hormone (hGH), in growth hormone deficient adults.

PROLOR is developing hGH-CTP to provide growth hormone deficient adults and children with hGH therapy that may require only once-weekly or bi-monthly injections, rather than the daily injections required by current hGH therapy. The initiation of the Phase III clinical trial follows a set of successful Phase II trials showing that hGH-CTP has the potential to be effective when injected once weekly. In these studies, hGH-CTP was shown to be well tolerated and safe, and it met all clinical endpoints.

The hGH-CTP Phase III trial is a randomized, placebo-controlled study to evaluate the efficacy and safety of hGH-CTP injected weekly in adults with growth hormone deficiency. The primary endpoint is defined as the change in truncal fat mass from baseline to six months after initiation of treatment. The trial is being conducted at clinical centers in the U.S., Europe and Israel.

Following regulatory review of the hGH-CTP Phase II data, PROLOR obtained clearance to use a pivotal Phase III trial design that includes a six-month assessment of efficacy and safety, followed by a subsequent six-month period of safety assessment. PROLOR's previous estimate and guidance had noted that a 12-month period of subsequent safety assessment might be required. This reduction of six months in the length of the required safety assessment and resulting reduction in the overall trial duration may enable PROLOR to submit an application for hGH-CTP marketing approval sooner than previously anticipated, subject to successful completion of the Phase III trial.

In the U.S., the Food and Drug Administration (FDA) has confirmed that the regulatory pathway for hGH-CTP is via a Biologics License Application (BLA), which would be submitted subject to the successful completion of the Phase III trial. The BLA pathway provides the manufacturer with 12 years of data exclusivity in the U.S., starting at the time of FDA approval.

Posted-In: News FDA

 

Related Articles (PBTH)

View Comments and Join the Discussion!
Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Premarket Activity
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Daily Analyst Rating
A summary of each day’s top rating changes from sell-side analysts on the street.
Fintech Focus
A daily collection of all things fintech, interesting developments and market updates.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at vipaccounts@benzinga.com