By Siddhi Mahatole
Aug 10 (Reuters) – AbCellera said on Monday its experimental menopause treatment significantly reduced the frequency and severity of hot flashes in a mid-stage trial, sending its shares up nearly 40% in early morning trading.
The drug, ABCL635, is being developed for women with moderate-to-severe vasomotor symptoms, commonly known as hot flashes, associated with menopause.
The data could bolster the drug’s prospects as a non-hormonal alternative to hormone therapy and as a potential rival to currently available therapies, including Astellas Pharma’s oral treatment Veozah.
In the 92-patient study, a single 600-mg dose of ABCL635 significantly reduced the frequency and severity of moderate-to-severe hot flashes compared with placebo after four weeks.
Patients treated with ABCL635 reported an 83% reduction in moderate-to-severe hot-flash frequency after four weeks, or 8.8 fewer hot flashes per day from baseline, compared with a 33% reduction, or 3.5 fewer events per day, in the placebo group.
ABCL635 also improved symptom severity, sleep and patients’ overall assessment of improvement.
BMO Capital Markets analyst Evan Seigerman said the positive trial results were “transformational” for AbCellera, estimating a global market opportunity of about $6 billion and forecasting potential peak annual sales of about $2.3 billion for ABCL635.
The most common side effects reported in patients treated with ABCL635 were headache, fatigue and injection-site reactions.
LONG-ACTING TREATMENT
The non-hormonal antibody therapy is being developed as a long-acting, once-monthly injection that targets the neurokinin 3 receptor, which helps regulate body temperature.
Sarah Noonberg, AbCellera’s chief medical officer, said the once-monthly injection could appeal to women already accustomed to self-injecting medicines, including breast cancer survivors and users of weight-loss drugs, and may improve adherence compared with daily pills.
Cantor analyst Steve Seedhouse said ABCL635 appeared more efficacious than even unapproved high doses of Astellas’ Veozah, which were discontinued in development due to liver safety concerns.
AbCellera said additional 12-week data from the trial are expected later this year.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Tasim Zahid)
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