AbCellera has dosed the first patient in the Phase II portion of its ongoing Phase I/II clinical trial evaluating ABCL635 for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause.
The move to Phase II comes after an interim assessment of safety, tolerability, and pharmacodynamic data collected from healthy volunteers in the Phase I stage.
The Phase II segment is a randomised, double-blind, placebo-controlled, multi-centre study designed to assess the efficacy of ABCL635 in minimising both severity and frequency of VMS in 80 postmenopausal women.
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AbCellera has updated the ABCL635 Phase I trial to a combined Phase I/II study, which now features a randomised Phase II proof-of-concept segment (Part C) for the appropriate patient population.
With Phase II enrolment currently in progress, AbCellera expects to report top-line results from both phases in Q3 2026.
ABCL635 is regarded as a potential first-in-class antibody therapy intended for the non-hormonal management of moderate-to-severe VMS, also known as hot flashes.
The therapy acts by targeting NK3R, a clinically validated G protein-coupled receptor (GPCR) found on kisspeptin, neurokinin, and dynorphin (KNDy) neurons within the infundibular nucleus of the hypothalamus.
AbCellera chief medical officer Sarah Noonberg said: “Advancing this programme into Phase II marks an important milestone in our clinical development efforts.
“Based on encouraging safety and pharmacodynamic data in the Phase I dose escalation portion, along with evidence of high target engagement and a strong mechanistic foundation, we are eager to evaluate ABCL635 in a randomised, double-blind Phase II study.
“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.”
ABCL635 is the first candidate from AbCellera’s GPCR and ion channel platform to progress into clinical development, having entered clinical trials in July 2025.
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