AbCellera Advances ABCL635 to Phase 2 Trial for Non-Hormonal Menopause Treatment
Key Insights
AbCellera has dosed the first patients in the Phase 2 portion of its clinical trial for ABCL635, a potential first-in-class non-hormonal treatment for moderate-to-severe vasomotor symptoms (search) associated with menopause (search).
The Phase 2 study is a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate ABCL635's efficacy in reducing hot flash frequency and severity in 80 postmenopausal women.
ABCL635 specifically targets NK3R (search), a G protein-coupled receptor on KNDy neurons (search) in the hypothalamus, representing the first program from AbCellera's GPCR (search) platform to advance into clinical development.
AbCellera has initiated dosing of the first patients in the Phase 2 portion of its ongoing Phase 1/2 clinical trial for ABCL635, marking a significant milestone for the potential first-in-class non-hormonal treatment targeting moderate-to-severe vasomotor symptoms (search) (VMS) associated with menopause (search). The advancement follows an interim review of encouraging safety, tolerability, and pharmacodynamic data from healthy volunteers in the Phase 1 portion of the study.
Phase 2 Trial Design and Objectives
The Phase 2 portion represents a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of ABCL635 in reducing the frequency and severity of VMS in 80 postmenopausal women. This transition to Phase 2 was supported by evidence of high target engagement and a strong mechanistic foundation observed in the earlier phase.
"Advancing this program into Phase 2 marks an important milestone in our clinical development efforts. Based on encouraging safety and pharmacodynamic data in the Phase 1 dose escalation portion, along with evidence of high target engagement and a strong mechanistic foundation, we are eager to evaluate ABCL635 in a randomized, double-blind Phase 2 study," said Sarah Noonberg, M.D., Ph.D., Chief Medical Officer of AbCellera.
Novel Mechanism of Action
ABCL635 represents a potential breakthrough in menopause (search) treatment through its specific targeting of NK3R (search), a clinically validated G protein-coupled receptor (GPCR (search)) expressed on kisspeptin, neurokinin, and dynorphin (KNDy) neurons in the infundibular nucleus of the hypothalamus. This mechanism offers a non-hormonal approach to managing hot flashes (search), addressing a significant unmet medical need for women seeking alternatives to hormone therapy.
The drug candidate is the first program from AbCellera's GPCR (search) and ion channel platform to advance into the clinical pipeline, having entered the clinic in July 2025. This milestone demonstrates the company's expanding capabilities beyond traditional antibody discovery into specialized receptor targeting.
Clinical Timeline and Expectations
AbCellera has recently redesignated the ABCL635 Phase 1 trial as a Phase 1/2 trial, which includes the randomized Phase 2 Proof-of-Concept study (Part C) in the appropriate patient population. With Phase 2 enrollment now underway, the company anticipates releasing top-line clinical results for both phases in Q3 2026.
Dr. Noonberg emphasized the clinical significance of the program, stating, "Menopausal symptoms can have a profound impact on quality of life, and we look forward to evaluating the potential of ABCL635 to provide a safe and effective option for women seeking non-hormonal symptom relief."
Company Background and Strategic Focus
AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines across multiple therapeutic areas, including endocrinology, women's health, immunology, and oncology. The advancement of ABCL635 into Phase 2 represents a key milestone in the company's diversification beyond its established antibody discovery platform into specialized therapeutic targets.