Acer is pausing the ACER-801 program until Acer has conducted a thorough review of the full data set. Concurrently, Acer is continuing to focus on preparation for its commercial launch of OLPRUVA™ (sodium phenylbutyrate) for oral suspension for the treatment of urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS), and the ongoing pivotal Phase 3 clinical evaluation of EDSIVO™ (celiprolol) for vascular Ehlers-Danlos Syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation, subject in each instance to availability of additional capital beyond early in Q2 2023.
“We are surprised and disappointed the Phase 2a trial did not meet its efficacy objectives in treating VMS given the extensive body of non-clinical and clinical evidence previously generated,” stated Chris Schelling, CEO and Founder of Acer. “We intend to conduct a comprehensive analysis of the totality of the clinical trial data – including the pharmacokinetic data, which has not yet been analyzed."
https://finance.yahoo.com/news/acer-therapeutics-announces-topline-results-123000801.html
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.