Benzinga | Dec 9, 2021 09:47PM EST

Acer Therapeutics Announces ACER-801 IND Clearance For The Treatment Of Induced Vasomotor Symptoms

Acer Therapeutics Inc. (NASDAQ:ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for its selective non-peptide neurokinin 3 receptor (NK3R) antagonist, ACER-801 (osanetant), for the potential treatment of induced Vasomotor Symptoms (iVMS).

The initial randomized, double-blind, placebo-controlled, dose-ranging Phase 2a trial is expected to begin in Q1 2022, subject to additional capital required for ACER-801 clinical development. The trial is designed to evaluate the effect of ACER-801 at different doses, compared to placebo, on the frequency and severity of vasomotor symptoms associated with menopause. The trial will also evaluate the safety and pharmacokinetics profile of ACER-801 at different doses in postmenopausal women.

"Submission and clearance of our ACER-801 IND application is an important step toward the clinical development of our novel NK3R antagonist for treatment of iVMS," said Chris Schelling, Chief Executive Officer and Founder of Acer. "This drug has been extensively studied, with over 1,200 individuals having received it in clinical trials for other non-iVMS indications. We're excited to start this Phase 2a trial which, if positive, will provide proof of concept data and help define ACER-801's optimal dose and development path forward in patients with iVMS."

ACER-801 is an investigational product candidate which has not been approved by FDA or any other regulatory authority. There is no guarantee that this product candidate will receive regulatory authority approval in any territory or become commercially available for any indications.