WALTHAM, Mass. – December 8, 2020 – Sojournix, a clinical-stage biopharmaceutical company developing transformative medicines for women’s health and neuroendocrine disorders, today announced that it has resumed its Phase 2 trial of SJX-653, a novel, potent, and selective neurokinin 3 (NK3) antagonist in development as a non-hormonal once-daily treatment for moderate to severe vasomotor symptoms (VMS) due to menopause, commonly called hot flashes. The Phase 2 trial was paused earlier this year due to COVID-19 and has now been amended and resumed with a streamlined design and integration of remote clinical trial techniques to reduce in-person contact and help safeguard the safety of patients and study personnel during the pandemic.
“We are pleased to progress Phase 2 clinical development of SJX-653 under an amended study protocol that incorporates safeguards for patients and study personnel during the COVID-19 pandemic and a simplified design to drive timely execution,” said Ruth Thieroff-Ekerdt, MD, Chief Medical Officer at Sojournix. “SJX-653 has the potential to offer an important nonhormonal treatment option for menopausal hot flashes, with high NK3 selectivity and a long half-life supportive of once daily (QD) dosing for treatment of both daytime and nighttime symptoms.”
The Phase 2 clinical trial is a four-week, multi-center, multi-national, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of SJX-653 in reducing the frequency and severity of moderate to severe VMS, as well as improving measures of quality of life and sleep. Following a screening period, participants are randomized to receive either SJX-653 or placebo administered orally once-daily each morning. The study is anticipated to enroll approximately 66 postmenopausal women and results are expected in the second half of 2021.
SJX-653 is a novel, potent, and selective neurokinin 3 (NK3) antagonist in Phase 2 clinical development as a non-hormonal once-daily (QD) therapy for moderate to severe vasomotor symptoms (VMS) due to menopause. 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 Vasomotor Symptoms (VMS)
Vasomotor symptoms (VMS), or hot flashes, are sudden sensations of intense heat, sweating, and skin reddening that can occur frequently in menopausal women. VMS occur both during the day and night, disrupting daily activities and sleep, and 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 new non-hormonal approach.
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.
Posted: December 2020
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