ACER - Acer Therapeutics wins FDA nod for hot flashes trial

Acer Therapeutics (NASDAQ:ACER) has gained ~3.3% in the pre-market after announcing the FDA clearance of its Investigational New Drug (IND) application for ACER-801 (osanetant) as a treatment for induced Vasomotor Symptoms ((iVMS)). ACER-801 is a non-hormonal drug designed as a selective non-peptide neurokinin 3 receptor (NK3R) antagonist. VMS — also known as hot flashes, flushing, and night sweats — tend to occur in or around menopause. Subject to additional funding for clinical advancement of ACER-801, a Phase 2a trial is likely to commence in Q1 2022. The placebo-controlled study will be designed to assess the effect of multiple doses of the drug on vasomotor symptoms linked to menopause. “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 (ACER) CEO Chris Schelling remarked. In October, the company shares gained

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Acer Therapeutics wins FDA nod for hot flashes trial