Ogeda reports positive top-line data from Phase IIa trial of fezolinetant to treat menopausal hot flashes


Belgium-based clinical-stage drug discovery company Ogeda has reported positive top-line data from its Phase IIa trial of fezolinetant (ESN364) to treat menopausal hot flashes (HF).

Fezolinetant (ESN364) is a proprietary, orally administered small-molecule developed as an antagonist of the G-protein coupled receptors (GPCRs) known as the tachykinin NK3 receptor.

It targets specific neurons that control body temperature to copy the effects of estrogen in a non-hormonal manner to address HF in menopausal women.

The Phase IIa trial was conducted as a double-blind, placebo-controlled, 12-week study, which treated 80 menopausal women experiencing a minimum of 49 moderate-to-severe HF per week who were randomised into two cohorts and treated with fezolinetant and placebo.

It is reported that a 93% reduction in the frequency of HF was observed after 12 weeks of treatment with fezolinetant compared with placebo.

"We are excited and committed to develop fezolinetant as a potential breakthrough treatment option for patients suffering from menopausal HF."

Patients have also experienced 70% reduction in HF severity after 12 weeks of treatment.

The study also reached its secondary endpoints that were achieving improvement in quality of life, which was determined on the basis of hot flash related daily interference scale (HFRDIS).

Ogeda CEO Jean Combalbert said: “These positive results demonstrate that menopausal women may finally be able to look forward to a rapid, effective and safe non-hormonal treatment for menopausal HF, a treatment option that has been demanded for a long time.

“Chronic use of Hormone Replacement Therapy (HRT), estrogen-based drugs currently dominating the menopausal HF market, is associated with various health risks.

“We are excited and committed to develop fezolinetant as a potential breakthrough treatment option for patients suffering from menopausal HF.”

The top-line data has prompted Ogeda to proceed with a large-scale Phase IIb study of fezolinetant to treat menopausal HF this year.