AbCellera Reports Positive Phase 2 Results for ABCL635

VANCOUVER, British Columbia, August 10, 2026

VANCOUVER, British Columbia, August 10, 2026

AbCellera Biologics Inc. announced positive topline results from the Phase 2 portion of its Phase 1/2 clinical trial evaluating ABCL635, an investigational neurokinin 3 receptor (NK3R) antagonist antibody being developed as a non-hormonal, long-acting treatment for moderate-to-severe vasomotor symptoms (VMS) associated with menopause. The randomized, double-blind, placebo-controlled study enrolled 92 postmenopausal women, with participants receiving either a single subcutaneous 600 mg dose of ABCL635 or placebo. At Week 4, the study met its primary efficacy endpoints, demonstrating statistically significant reductions in both the frequency and severity of moderate-to-severe hot flashes compared with placebo. ABCL635 also produced meaningful improvements in sleep and patient global impression of change, highlighting the potential of the investigational therapy to address multiple effects of menopausal VMS.

ABCL635 Demonstrates Strong Reduction in Hot Flash Frequency and Severity

AbCellera reported that ABCL635 produced a substantial reduction in the frequency of moderate-to-severe vasomotor symptoms after a single dose. At Week 4, patients receiving ABCL635 experienced a mean reduction of 8.8 moderate-to-severe events per day from baseline, compared with a 3.5-event reduction for placebo, resulting in a placebo-adjusted treatment difference of 5.3 events per day (p<0.001). The mean percentage reduction in symptom frequency reached 83% with ABCL635, compared with 33% with placebo. The therapy also demonstrated significant improvements in symptom severity, with a mean reduction of 1.4 points versus 0.3 points for placebo and a placebo-adjusted treatment difference of 1.1 points (p<0.001). The mean reduction in symptom severity was 58% with ABCL635, compared with 12% with placebo. Statistical significance was maintained from Week 1 through Week 4, suggesting a rapid treatment effect following administration.

Treatment Also Improves Sleep With Favorable Tolerability

Beyond reducing hot flash frequency and severity, ABCL635 significantly improved sleep scores and patient global impression of change, potentially addressing important quality-of-life consequences associated with menopausal VMS. Vasomotor symptoms such as hot flashes and night sweats can disrupt sleep, concentration, energy, mood and daily activities, making effective symptom control an important unmet medical need. The Phase 2 safety analysis showed that ABCL635 was well tolerated over the four-week treatment period, with no serious adverse events, severe adverse events or adverse events leading to treatment discontinuation. The most common adverse events reported more frequently with ABCL635 than placebo were headache, fatigue and injection-site reactions. The findings support continued clinical development of the investigational antibody, although the Phase 2 results will need to be confirmed in larger and longer studies before the potential efficacy and safety profile of ABCL635 can be fully established.

ABCL635 Supports Next-Stage Development in Women’s Health

AbCellera is developing ABCL635 as a potential long-acting, non-hormonal therapy targeting NK3R, a receptor expressed on KNDy neurons in the hypothalamus that has been clinically validated as a mechanism for treating menopausal vasomotor symptoms. The company said the Phase 2 findings represent an important milestone for the program and demonstrate the potential for a single subcutaneous dose to provide meaningful symptom relief. The Phase 2 study, registered as NCT07118891, evaluated postmenopausal women with moderate-to-severe VMS associated with menopause. AbCellera previously advanced ABCL635 into the clinic in July 2025 as the first program from its GPCR and ion-channel discovery platform to reach clinical development. The company will need to generate additional clinical evidence in subsequent development before ABCL635 could potentially progress toward regulatory approval. The positive Phase 2 findings strengthen AbCellera’s position in women’s health and support further development of ABCL635 as a potentially convenient non-hormonal treatment for menopausal hot flashes.

Source:AbCellera press release