AbCellera (NASDAQ:ABCL) shares jumped 22% on Monday after the biotechnology company announced positive topline results from a Phase 2 clinical trial evaluating ABCL635 as a potential treatment for moderate-to-severe vasomotor symptoms associated with menopause.
The study achieved its primary efficacy endpoints, demonstrating statistically significant reductions in both the frequency and severity of moderate-to-severe vasomotor symptoms at week four following a single dose compared with placebo.
The trial also produced improvements in sleep and patients’ global impression of change, providing additional encouraging signals for the investigational therapy.
ABCL635 significantly reduces hot flash frequency
The randomised, double-blind and placebo-controlled Phase 2 trial enrolled 92 postmenopausal women who were experiencing approximately 10 moderate or severe hot flashes per day.
Participants received either a single 600 mg subcutaneous dose of ABCL635 or a placebo.
At week four, women treated with ABCL635 experienced a reduction of 8.8 moderate-to-severe vasomotor symptom events per day from baseline, compared with a decrease of 3.5 events among participants receiving placebo.
That translated into a placebo-adjusted treatment difference of 5.3 events per day.
The therapy also demonstrated an improvement in symptom severity. ABCL635 reduced severity by 1.4 points at week four, compared with a 0.3-point reduction for placebo, resulting in a placebo-adjusted difference of 1.1 points.
Trial reports favourable safety profile
ABCL635 was generally well tolerated throughout the four-week treatment period, with no serious adverse events, severe adverse events or adverse events resulting in participants discontinuing the study.
The most commonly reported adverse events among patients receiving ABCL635 were headache, fatigue and injection-site reactions.
The combination of statistically significant efficacy results and a favourable safety profile provided the catalyst for the sharp rise in AbCellera shares following the announcement.
AbCellera targets non-hormonal menopause treatment market
AbCellera is developing ABCL635 as a long-acting, non-hormonal therapy targeting the neurokinin 3 receptor.
The treatment is administered through a subcutaneous injection and is being developed as a potential alternative for women experiencing moderate-to-severe vasomotor symptoms associated with menopause.
The Phase 2 findings provide important clinical validation for the programme, particularly as a single dose continued to demonstrate benefits at the four-week assessment.
AbCellera held a conference call on Monday to discuss the trial findings and provide additional context around the development programme.
With the study meeting its primary endpoints while showing improvements in additional patient measures, investors responded strongly to the clinical update, sending AbCellera (NASDAQ:ABCL) shares approximately 22% higher during Monday’s session.