Acer Therapeutics Inc., a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, has reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for its pivotal Phase 3 DiSCOVER (Decentralized Study of Celiprolol on vEDS-related Event Reduction) clinical trial of EDSIVO™ (celiprolol) for the treatment of patients with COL3A1-positive vascular Ehlers-Danlos Syndrome (vEDS). In April 2022, FDA granted celiprolol Breakthrough Therapy designation in the U.S.
The SPA agreement is a process through which sponsors may seek agreement with FDA on the design and size of certain clinical trials, clinical studies, or animal studies. Agreement on Acer’s Phase 3 trial design indicates concurrence by FDA with the adequacy and acceptability of specific critical elements of the overall protocol design that could support a future regulatory submission and marketing application if the trial results meet the agreed-upon criteria. For more information on Special Protocol Assessments, please visit: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-protocol-assessment-guidance-industry.
“Receiving SPA agreement from FDA is a significant milestone in our ongoing development of EDSIVO™ for patients with COL3A1-positive vEDS, who urgently need an approved treatment for this devastating disease,” said Adrian Quartel, MD, CMO of Acer. “The SPA underscores our alignment with FDA on important regulatory, clinical and scientific requirements for our planned Phase 3 trial and reflects our ongoing commitment to the vEDS patient community. We are planning for trial initiation by the end of Q2 2022.”
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