Topline results from ACER 801 phase IIa trial for moderate to severe vasomotor symptoms associated with menopause.- Acer Therapeutics
Acer Therapeutics Inc. announced that topline results from its Phase IIa proof of concept clinical trial to evaluate ACER 801 (osanetant) as a potential treatment for moderate to severe Vasomotor Symptoms (VMS) associated with menopause 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.
As a result, 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 III3 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 IIa 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 – which will inform our path forward for the program, including our collaborations for prostate cancer and post-traumatic stress disorder (PTSD). We wish to thank the patients, investigators and partners who participated in this clinical trial. We remain committed to our mission to provide transformative treatments to underserved and overlooked patients with rare and life-threatening diseases and will continue to focus our resources on launch preparation for our FDA-approved product, Olpruva, for oral suspension for the treatment of UCDs involving deficiencies of CPS, OTC or AS, as well as our pivotal Phase III clinical trial of dDsivo for vEDS.”
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