Acer Therapeutics announces full enrollment in Phase 2a trial of ACER-801

Acer Therapeutics announced full enrollment of its Phase 2a proof of concept trial of ACER-801, a novel, non-hormonal, neurokinin 3 receptor antagonist, being investigated as a potential treatment option for moderate to severe Vasomotor Symptoms, VMS, associated with menopause. Topline results from this trial are expected in mid-March 2023. The Phase 2a randomized, double-blind, placebo-controlled, dose-ranging trial of ACER-801 is designed to evaluate the safety, pharmacokinetics and efficacy of ACER-801 in 48 postmenopausal women aged 40-65 who experience moderate to severe hot flashes. Subjects were randomized 1:1:1:1 and receive twice daily doses of either 50mg, 100mg, 200mg of ACER-801 or placebo over a 14-day treatment period, followed by a 14-day safety follow-up assessment. Results from this trial could provide proof of concept data in postmenopausal women and could inform ACER-801 dosing and a development path forward in patients with induced Vasomotor Symptoms.