ACER-801 (osanetant) is an investigational non-hormonal, neurokinin 3 receptor (NK3R) antagonist that is being developed as a potential treatment option for patients with VMS, including menopause-related VMS (MR-VMS) and induced VMS (iVMS), as well as post-traumatic stress disorder (PTSD), and prostate cancer. In December 2018, we entered into an exclusive license agreement with Sanofi to acquire worldwide rights to ACER-801.
In March 2023, we announced that topline results from our Phase 2a proof of concept clinical trial to evaluate ACER-801 as a potential treatment for moderate to severe 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, we are pausing the ACER-801 program until we have conducted a thorough review of the full data set.
ACER-801 Registration Plan (Prostate Cancer)
In Jan. 2023, Acer announced the initiation of two Phase 2, single-arm investigator-sponsored trials evaluating ACER-801 (osanetant) in men with adenocarcinoma of the prostate. The POSH-MAP (Pilot of Osanetant for Severity of Hot Flashes in Men with Adenocarcinoma of the Prostate) and PORT-MAP (Pilot of Osanetant to Reduce Testosterone in Men with Adenocarcinoma of the Prostate) trials are evaluating ACER-801’s (osanetant) ability to reduce hot flashes and its potential as neoadjuvant therapy in men with prostate cancer. The trials are sponsored and conducted by The University of Kansas Cancer Center in partnership with Acer.
Acer is pausing the ACER-801 program until Acer has conducted a thorough review of the full data set from the Phase 2a proof of concept clinical trial to evaluate ACER-801 as a potential treatment for moderate to severe VMS associated with menopause.
ACER-801 is an investigational drug in the U.S. and is not currently FDA approved for any indication. There is no guarantee that this product candidate will receive regulatory authority approval in any territory or become commercially available for any indications.