Acer Therapeutics Inc. has announced it will be conducting a pivotal clinical trial in patients with COL3A1+ vascular Ehlers-Danlos Syndrome (VEDS) called the DiSCOVER Trial (Decentralized Study of Celiprolol On VEDS-Related Event Reduction).
The study is planned to be a phase 3, randomized, double-blind, placebo-controlled, decentralized clinical trial. Decentralized means that travel is not likely required, patients can participate from home, and there are no specific study sites established around the country. A Contract Research Organization (CRO) will facilitate the trial and communicate directly with patients for status updates and to provide medication for the study. Acer anticipates that the trial should enroll approximately 200 COL3A1+ VEDS patients in the U.S., and the duration of the clinical trial is estimated to be approximately 3.5 years to complete once fully enrolled.
Chris Schelling, CEO and Founder of Acer stated, “This trial, along with the results from the prior BBEST trial, should answer whether EDSIVO™ demonstrates substantial evidence of effectiveness by reducing VEDS-related events. Over the next six months, we intend to work closely with FDA to finalize the protocol for the pivotal trial, collaborate with VEDS advocacy groups to identify COL3A1+ patients who may be interested in participating in the trial in order to expedite enrollment, and achieve first patient dosed as quickly as possible. Our progress to date on the EDSIVO™ program is the direct result of our unwavering and ongoing commitment to patients with rare diseases. We look forward to continuing its development for treatment of VEDS patients who desperately need a therapy.”
“We are encouraged that Acer is conducting this clinical trial of celiprolol to definitively determine whether celiprolol is effective in reducing life-threatening complications of VEDS,” said Katie Wright, Director of The VEDS Movement, “We are hopeful that the trial reveals a clear answer to this question and brings us closer to a treatment for VEDS.”
For more information on the trial from Acer as it becomes available, please visit: www.discoverceliprolol.com
The VEDS Movement will also provide updates on the progress of trial details and provide any other relevant information as it becomes available. We encourage individuals and family members with VEDS to sign up for updates on The VEDS Movement website.
About The VEDS Movement
The VEDS Movement is dedicated to improving the quality of life and saving lives of individuals affected by Vascular Ehlers-Danlos Syndrome through research, patient support, education, and awareness. A division of The Marfan Foundation, the Movement has the support of a large, diverse Professional Advisory Board, consisting of leading experts across the country on VEDS, Marfan Syndrome, Loeys-Dietz, and related genetic aortic conditions. Learn more and get involved.