Sojournix, a clinical stage biopharmaceutical company focused on developing and commercializing novel therapies for the treatment of women’s health and neuroendocrine disorders, today announced positive top-line data from a first-in-human Phase 1 clinical study of SJX-653. SJX-653 is a novel, selective, neurokinin-3 (NK3) antagonist in development as a once-daily (QD) non-hormonal therapy for menopausal vasomotor symptoms (VMS) or “hot flashes.” In this study SJX-653 demonstrated clinical proof-of-mechanism through statistically significant and dose-dependent activity on pharmacodynamic markers of NK3 receptor target engagement, once-daily pharmacokinetics, and a well-tolerated profile.
This randomized, placebo-controlled, double-blind, single ascending dose (SAD) escalation study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered SJX-653. To demonstrate proof-of-mechanism, the study was performed in healthy adult men (N=42) and measured changes in luteinizing hormone (LH) and total testosterone (T) levels. LH and T levels in men are known to be especially sensitive to NK3 antagonists. Consequently, LH and T have become established pharmacodynamic markers of NK3 receptor target engagement and useful for demonstrating NK3 antagonist clinical proof-of-mechanism.
Sojournix is also evaluating SJX-653 in ongoing Phase 1 studies in postmenopausal women, the target population for vasomotor symptoms.
“In this initial Phase 1 study, SJX-653 significantly reduced levels of LH and T in men in a potent, dose-dependent, and reversible manner, indicating proof-of-mechanism and NK3 receptor target engagement,” commented Professor Richard Anderson, the Elsie Inglis Professor of Clinical Reproductive Science at the University of Edinburgh. “The pharmacokinetic and pharmacodynamic relationship data from this study, combined with data from the ongoing Phase 1 studies in postmenopausal women, will help inform the selection of doses for a Phase 2 clinical trial of SJX-653 for the treatment of moderate to severe vasomotor symptoms.”
“We are pleased with the results from this first-in-human trial with SJX-653, demonstrating NK3 mediated pharmacodynamic responses and providing initial clinical evidence of a favorable tolerability and pharmacokinetic profile,” said Daniel Grau, President and CEO of Sojournix. “In advancing SJX-653 for the treatment of menopausal vasomotor symptoms, we aim to address the well-recognized unmet medical need among patients for a safe and effective non-hormonal treatment option.”
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