Non-Hormonal Menopause Drug Cuts Hot Flashes Sharply in Mid-Stage Trial

An experimental non-hormonal medicine being developed by biotechnology company AbCellera has produced encouraging results in a mid-stage clinical trial involving women experiencing moderate-to-severe menopausal hot flashes.

The drug, known as ABCL635, was tested in a study involving 92 patients with vasomotor symptoms associated with menopause. A single 600-milligram dose produced a significant reduction in both the frequency and severity of symptoms after four weeks, according to the company and data reported by Reuters.

Women receiving ABCL635 reported an average 83% reduction in moderate-to-severe hot-flash frequency, equivalent to 8.8 fewer episodes per day from baseline. Patients receiving placebo experienced a 33% reduction, or 3.5 fewer episodes per day.

The treatment also improved measures of symptom severity, sleep and patients' overall assessments of how they were feeling. ABCL635 works by blocking the neurokinin-3 receptor, known as NK3R, which is involved in regulation of body temperature.

This represents an increasingly important field of menopause medicine. Hormone replacement therapy can be effective for many women experiencing menopausal symptoms, but it may not be medically appropriate or preferred by every patient. Researchers are therefore developing additional non-hormonal approaches.

Hot flashes and night sweats are among the most common menopausal symptoms and can have significant effects on sleep, employment, concentration and quality of life.

The results nevertheless require caution. ABCL635 remains an experimental drug. A successful Phase 2 study does not establish that a medicine is ready for routine clinical use. Larger and longer clinical trials will be required to confirm the scale of the benefit, determine how long its effects last and identify less common safety problems that a 92-person study may not reveal. Regulators would also need to evaluate the full clinical evidence before the medicine could be approved.

Investors responded positively to the results, reflecting commercial interest in menopause treatment as pharmaceutical companies devote greater resources to an area that historically received less research attention than many other major health conditions.

For patients, however, the most important conclusion is simpler: the findings are promising, but ABCL635 is not yet an approved treatment.

Source attribution: AbCellera Phase 2 clinical-trial results; Reuters.