Non-hormonal treatment for menopausal hot flashes begins clinical trials

The study will evaluate the efficacy of SJX-653 in reducing the frequency and severity of VMS due to menopause, as well as improving measures of sleep and quality of life.

“Though millions of women suffer from hot flashes, current therapies for VMS often leave women searching for better alternatives,” said Ruth Thieroff-Ekerdt, Chief Medical Officer at Sojournix. “Many women choose to avoid hormone therapy, and current non-hormonal options often provide unsatisfactory symptom relief. Women and their doctors need new non-hormonal treatment options with meaningful clinical efficacy, and SJX-653 aims to address this important unmet medical need.”

The Phase II clinical trial is a 12-week, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of SJX-653 in reducing the frequency and severity of vasomotor symptoms (VMS) due to menopause, as well as improving measures of sleep and quality of life. Following a screening period, participants will be randomized to receive one of two doses of SJX-653 or placebo administered orally once-daily (QD) each morning. The study is anticipated to enroll approximately 130 postmenopausal women who are experiencing moderate to severe VMS.

“The progression of SJX-653 into this Phase II clinical trial represents a significant milestone in bringing SJX-653 to patients,” said Daniel Grau, CEO and President of Sojournix. “NK3 antagonism is a well-validated mechanism of action, and we believe SJX-653 has the potential to become a new standard of care medicine for menopausal women seeking non-hormonal treatment options for VMS.”