Sojournix Announces Initiation of Phase 2 Clinical Trial of SJX-653, a Novel Selective NK3 Antagonist for Menopausal Hot Flashes

February 24, 2020 |

3 min read

Sojournix, a clinical-stage biopharmaceutical company developing transformative medicines for women’s health and neuroendocrine disorders, today announced the initiation of a Phase 2 trial of SJX-653, a novel, potent, selective neurokinin 3 (NK3) antagonist in clinical development as a non-hormonal once-daily (QD) treatment for moderate to severe vasomotor symptoms (VMS) due to menopause, commonly called hot flashes.

WALTHAM, Mass.--(BUSINESS WIRE)-- Sojournix, a clinical-stage biopharmaceutical company developing transformative medicines for women’s health and neuroendocrine disorders, today announced the initiation of a Phase 2 trial of SJX-653, a novel, potent, selective neurokinin 3 (NK3) antagonist in clinical development as a non-hormonal once-daily (QD) treatment for moderate to severe vasomotor symptoms (VMS) due to menopause, commonly called hot flashes.

“Though millions of women suffer from hot flashes, unfortunately current therapies for VMS often leave women searching for better alternatives,” said Ruth Thieroff-Ekerdt, MD, 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 2 clinical trial is a 12-week, multi-center, 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 2 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.”

NK3 antagonism is a clinically and genetically validated new approach for treating menopausal hot flashes. During menopause, declining estrogen levels lead to an over-production of neurokinin B (NKB), an endogenous neuropeptide that binds to and activates NK3 receptors. By reducing the excessive signaling of NKB through NK3 receptors in the hypothalamic area of the brain that regulates heat dissipation, SJX-653 is expected to alleviate vasomotor symptoms due to menopause.

About SJX-653

SJX-653 is a novel, potent, and selective neurokinin 3 (NK3) antagonist in clinical development as a non-hormonal once-daily (QD) therapy for moderate to severe vasomotor symptoms (VMS) due to menopause.

About Vasomotor Symptoms (VMS)

Vasomotor symptoms (VMS), or hot flashes, are sudden sensations of intense heat, sweating, and skin reddening that can occur frequently during the day and night, disrupting both daily activities and sleep. VMS are associated with increased rates of insomnia, depression, and cognitive impairment. More than 2 million women in the United States enter menopause each year and the majority experience VMS, with symptoms typically persisting for many years during and after menopause. Current treatment options are limited to hormone therapy, which patients and physicians often avoid due to safety concerns, or non-hormonal agents known to have limited efficacy. There is a significant unmet medical need for a safe and effective non-hormonal approach.

About Sojournix

Sojournix is a clinical-stage biopharmaceutical company dedicated to developing and commercializing transformative new medicines for the treatment of women’s health and neuroendocrine disorders. The company is developing SJX-653, a novel, potent, selective neurokinin 3 (NK3) antagonist as a non-hormonal once-daily therapy for moderate to severe vasomotor symptoms (commonly called hot flashes) due to menopause. NK3 antagonism is a clinically and genetically validated new approach to treating menopausal hot flashes that targets the excessive signaling of neurokinin B through NK3 receptors in the hypothalamic area of the brain that regulates heat dissipation. To learn more about Sojournix, please visit www.sojournixpharma.com.