
AbCellera reported positive Phase 2 results for ABCL635, a long-acting, nonhormonal antibody treatment for hot flashes in postmenopausal women, causing stock prices to surge up to 41%.
The biotech company’s study met its primary efficacy endpoints: reducing hot flash frequency and episode severity. Of the 92 postmenopausal women – who reported experiencing 10 moderate-to-severe hot flashes a day – those treated with a single 600 mg subcutaneous dose of ABCL635 had 83% fewer hot flashes after four weeks, compared to 33% in the placebo group. The drug, which targets the neurokinin-3 receptor (NK3R) to regulate body temperature, was well-tolerated and improved patients’ sleep quality and overall assessment of improvement
While 75% of women in menopause experience hot flashes, treatment has been limited to hormone replacement therapy, used by less than 50% of women, and lifestyle habits. A promising solution for the 2 million women entering menopause annually, AbCellera’s trials are ongoing to establish the drug’s safety and efficacy in the treatment of vasomotor symptoms.
“These positive results represent a significant milestone for women’s health and for AbCellera,” said Sarah Noonberg, M.D., Ph.D., Chief Medical Officer of AbCellera. “These data indicate that ABCL635 could offer menopausal women a well-tolerated, long-acting treatment that has the potential to markedly improve their quality of life.”