The pharmaceutical company, Acer Therapeutics Inc. (Nasdaq: ACER), focus on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, announcing this week that they are planning a pivotal clinical trial in patients with COL3A1+ vascular Ehlers-Danlos syndrome (vEDS) with the treatment EDSIVO™ (celiprolol).
Vascular EDS is a life-threatening connective tissue disorder that affects all tissues, arteries, and internal organs making them extremely fragile, it is estimated to affect 1 in 90,000 people. The clinical trial is seeking to identify if EDSIVO™ “demonstrates substantial evidence of effectiveness by reducing vEDS-related events.”
Acer anticipates that the trial should enroll approximately 200 COL3A1+ vEDS patients in the U.S. and that the duration of the clinical trial is estimated to be approximately 3.5 years to complete once fully enrolled. Over the next six months, Acer announced it intends to work closely with FDA to finalize the protocol for the clinical trial.
The Ehlers-Danlos Society will continue to update the community as information around the clinical trial becomes available.
