Acer Plans Pivotal Trial of Edsivo in COL3A1-positive vEDS

Acer Plans Pivotal Trial of Edsivo in COL3A1-positive vEDS

296612

Acer Plans Pivotal Trial of Edsivo in COL3A1-positive vEDS

Following a meeting with the U.S. Food and Drug Administration (FDA), Acer Therapeutics is planning to launch a potentially pivotal clinical trial to evaluate the safety and efficacy of its investigational therapy Edsivo (celiprolol). Edsivo was found in a small earlier trial to significantly reduce the rate of artery ruptures in people with COL3A1-positive vascular Ehlers-Danlos syndrome, known as vEDS. However, the FDA rejected Acer’s application for Edsivo’s approval, saying there was insufficient evidence of…

You must be logged in to read/download the full post.