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 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
About ACER-801 (osanetant)
ACER-801 (osanetant) is an investigational non-hormonal, neurokinin 3 receptor (NK3R) antagonist being studied for the potential treatment of patients with Vasomotor Symptoms (VMS), prostate cancer and post-traumatic stress disorder (PTSD). In
About
Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. In the
Acer currently believes that its existing cash and cash equivalents will be sufficient to fund its anticipated operating and capital requirements into early in the second quarter of 2023. Acer will require additional financing to commercialize OLPRUVA™ for oral suspension in the
Acer Forward-Looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. Examples of such statements include, but are not limited to, statements about the continued development of ACER-801 for treatment of VMS or other indications, the continued development of EDSIVO™, and launch preparations for OLPRUVA™. Our pipeline products (including ACER-801) are under investigation and their safety and efficacy have not been established and there is no guarantee that any of our investigational products in development will receive health authority approval or become commercially available for the uses being investigated. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the availability of financing to fund our pipeline product development programs, commercialization efforts and general corporate operations as well as risks related to drug development and the regulatory approval process, including the timing and requirements of regulatory actions. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the
Corporate and IR Contacts
jdenike@acertx.com
+1-844-902-6100
nick@gilmartinIR.com
+1-332-895-3226
Source:
2023 GlobeNewswire, Inc., source