Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 DOR Gets SPA Clearance for orBec Trial | Contract Pharma

What are you searching for?

Sign in
Breaking News, Trials & Filings

DOR Gets SPA Clearance for orBec Trial

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

DOR BioPharma, Inc. has reached agreement with the FDA on the design of a confirmatory Phase III trial for its lead product orBec for the treatment of acute gastrointestinal Graft-versus-Host Disease (GI GVHD). The agreement was made under the FDA’s Special Protocol Assessment (SPA) procedure.

The SPA is an agreement with the FDA regarding the trial’s design, including endpoints, sample size, control group and statistical analyses. The design has been deemed acceptable to support a regulatory submission seeking new drug approval. Once the study begins, the FDA can only change an SPA for very limited reasons.

The confirmatory study will be a double-blind, randomized, placebo-controlled, multi-center trial that will enroll approximately 166 patients. The primary endpoint is the treatment failure rate at study day 80. 

“We are very pleased to gain SPA agreement with the FDA,” stated Christopher J. Schaber, Ph.D., president and chief executive officer of DOR. “The depth and strength of our available Phase III data have allowed us to design and power this pivotal trial that we believe maximizes orBec’s chances for success. With our primary endpoint of the ‘treatment failure rate at Study Day 80,’ we expect to replicate statistical significance in this clinically meaningful endpoint with orBec. We expect to initiate this trial in the first half of 2009.”

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters