Acer Therapeutics' Product Acquired From Sanofi Fails In Menopause Study

  • Acer Therapeutics Inc ACER announced topline results from its Phase 2a proof of concept clinical trial to evaluate ACER-801 (osanetant) as a potential treatment for moderate to severe Vasomotor Symptoms (VMS) associated with menopause.
  • The study showed that ACER-801 was safe and well-tolerated but did not achieve statistical significance when evaluating ACER-801's ability to decrease the frequency or severity of hot flashes in postmenopausal women.
  • Related: Acer Therapeutics Expands ACER-801 Development Into Post-Traumatic Stress Disorder.
  • Hence, Acer is pausing the ACER-801 program until Acer has thoroughly reviewed the full data set. 
  • Acer is continuing to focus on preparation for its commercial launch of OLPRUVA (sodium phenylbutyrate) for urea cycle disorders and the ongoing Phase 3 trial of EDSIVO (celiprolol) for vascular Ehlers-Danlos Syndrome in patients with a confirmed type III collagen mutation, subject to availability of additional capital beyond early in Q2 2023.
  •  In December 2018, Acer entered into an exclusive license agreement with Sanofi SA SNY to acquire worldwide rights to ACER-801 (osanetant).
  • Price Action: ACER shares are down 39.96% at $0.9306 on the last check Friday.
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