AbCellera has unveiled Phase 2 results for its menopause therapy that substantially exceeded the company’s own expectations, strengthening its position in the race to compete with Bayer and Astellas in the growing market for non-hormonal treatments for menopausal hot flashes.
The Phase 2 study evaluated ABCL635, an antibody targeting the neurokinin 3 receptor (NK3R), against placebo in postmenopausal women experiencing vasomotor symptoms. The trial enrolled 92 participants who reported an average of approximately 10 moderate-to-severe hot flashes each day. After four weeks of treatment, women receiving ABCL635 experienced an average reduction of 8.8 hot flashes per day, compared with a 3.5 reduction in the placebo group.
The placebo-adjusted reduction of 5.3 moderate-to-severe hot flashes met the study’s primary goal and surpassed the efficacy reported for currently approved therapies, although direct comparisons between separate clinical trials should be interpreted cautiously.
Chief Executive Officer Carl Hansen said the company now believes ABCL635 has the potential to become a best-in-class non-hormonal therapy, citing what he described as meaningful advantages over currently approved NK3R treatments in areas including convenience, dosing, efficacy and safety. He also characterized the program as significantly de-risked following the positive findings.
Just a week earlier, Hansen had said the company would consider the study successful if ABCL635 demonstrated a favorable safety profile together with efficacy comparable to the two approved small-molecule NK3R therapies. The latest data exceeded those expectations.
The efficacy results also compared favorably with those reported for competing products. In pivotal Phase 3 trials, Astellas’ Veozah achieved placebo-adjusted reductions of 2.1 and 2.6 hot flashes at the fourth week, while Bayer’s Lynkuet demonstrated corresponding reductions of 3.04 and 3.29. By comparison, ABCL635 produced a placebo-adjusted reduction of 5.3.
In addition to reducing the frequency of hot flashes, the trial also met its key secondary objective of improving symptom severity. Participants treated with ABCL635 recorded an average reduction of 1.4 points in hot flash severity by the fourth week, compared with 0.3 points for placebo recipients. That placebo-adjusted improvement also compared favorably with results reported for Veozah and Lynkuet.
Analysts responded positively to the findings. BMO Capital Markets said the results strongly support ABCL635’s potential to become a best-in-class therapy. The analysts suggested the apparent efficacy advantage may stem from the antibody’s ability to achieve greater target engagement and higher effective dosing than oral competitors because of its broader therapeutic index.
BMO analysts, who estimate unadjusted peak annual sales of $2.3 billion for the therapy, also highlighted the safety profile as an important strength. Unlike Veozah, which carries a boxed warning for liver injury, no patients receiving ABCL635 experienced elevated bilirubin levels or liver enzyme abnormalities during the Phase 2 trial. If those findings are confirmed in Phase 3 testing, the therapy could potentially avoid the liver monitoring requirements associated with Veozah.
Investors reacted positively to the announcement, sending AbCellera shares up over 30% in premarket trading to $9.21, compared with the previous Friday’s closing price of $6.93.
AbCellera Reports Positive Phase 2 Results
AbCellera has reported encouraging Phase 2 results for ABCL635, an investigational antibody being developed for moderate-to-severe vasomotor symptoms associated with menopause. The results have increased attention around AbCellera and its growing drug-development pipeline.
The Phase 2 study found that a single dose of ABCL635 significantly reduced both the frequency and severity of hot flashes compared with placebo by the fourth week. AbCellera also reported improvements in sleep quality and overall well-being among participants.
