The trial will evaluate SJX-653 in reducing the frequency and severity of VMS. Credit: Darko Stojanovic from Pixabay.

Clinical-stage biopharmaceutical firm Sojournix has started a Phase II trial to evaluate the efficacy of SJX-653, a once-daily regimen for moderate to severe vasomotor symptoms (VMS), hot flashes, and night sweats associated with the menopause.

SJX-653 is a novel, potent, selective neurokinin 3 (NK3) antagonist in clinical development and is used as a non-hormonal treatment for VMS.

Sojournix chief medical officer Ruth Thieroff-Ekerdt said: “Though millions of women suffer from hot flashes, unfortunately, current therapies for VMS often leave women searching for better alternatives.

“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 12-week, multi-centered, randomised, double-blind, and placebo-controlled Phase II trial will evaluate SJX-653 in reducing the frequency and severity of VMS due to the menopause and also to improve measures of sleep in the patient.

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Under the trial, selected subjects will be randomised to receive one of two doses of SJX-653 or placebo through oral administration each morning.

The trial is expected to enroll about 130 postmenopausal women experiencing moderate to severe VMS.

Sojournix CEO and president Daniel Grau said: “The progression of SJX-653 into this Phase II clinical trial represents a significant milestone in bringing SJX-653 to patients.

“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.”