In early Phase II data, investigational antibody ABCL635 achieved all primary efficacy endpoints in postmenopausal women experiencing vasomotor symptoms, offering the potential for a long-acting, non-hormonal treatment option for an underserved population.
AbCellera has reported positive top-line Phase II data for ABCL635, an investigational antibody being developed as a long-acting, non-hormonal treatment for moderate-to-severe vasomotor symptoms associated with menopause. The study achieved its primary efficacy endpoints, with ABCL635 demonstrating statistically significant reductions in the frequency and severity of symptoms at week 4 compared with placebo.
ABCL635 targets the neurokinin-3 receptor (NK3R), located on KNDy neurons in the hypothalamus and involved in pathways that regulate body temperature. AbCellera is investigating whether targeting the receptor with an antibody could provide sustained symptom relief following a single dose.
The Phase II segment of the company’s Phase I/II study included 92 postmenopausal women experiencing an average of 10 moderate-to-severe hot flashes per day. In the study (NCT07118891), participants were randomised to receive either a single 600mg subcutaneous dose of ABCL635 or placebo.
At day 29, participants receiving ABCL635 experienced a mean reduction of 8.8 moderate-to-severe episodes per day from baseline, compared with 3.5 in the placebo group. The mean percentage reduction in episode frequency was 83% with ABCL635, compared with 33% with placebo.
These positive results represent a significant milestone for women’s health and for AbCellera.”
-Sarah Noonberg, Chief Medical Officer at AbCellera
ABCL635 also achieved a greater mean reduction in severity scores than placebo, while patients reported improvements in sleep and patient global impression of change. The treatment was generally well tolerated, with no serious or severe adverse events reported and no adverse events leading to treatment discontinuation.
Sarah Noonberg, Chief Medical Officer at AbCellera, said: “These positive results represent a significant milestone for women’s health and for AbCellera. By successfully targeting the NK3 receptor with an antibody, we have demonstrated potential best-in-class vasomotor symptom relief over four weeks with a single subcutaneous dose.”
The company is continuing the Phase II study to further assess the safety and efficacy of ABCL635 in this indication.
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