AbCellera has reported encouraging top-line data from the Phase II segment of its Phase I/II study assessing ABCL635, an investigational antibody being developed for moderate-to-severe vasomotor symptoms (VMSM-S), commonly referred to as hot flashes, linked to menopause.
The company is developing the antibody as a non-hormonal, long-acting subcutaneous treatment.
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The study achieved its primary efficacy endpoints, demonstrating statistically significant reductions in both the frequency and severity of VMSM-S at week four following a single administered dose, compared to placebo.
In addition, investigators observed improvements in sleep as well as patient global impression of change metric.
The double-blind, randomised, multi-centre, placebo-controlled Phase II segment involved 92 postmenopausal women who were experiencing an average of ten moderate or severe hot flashes a day.
Participants were assigned equally to receive either a single subcutaneous 600mg dose of ABCL635 or placebo.
Trial results showed that ABCL635 reduced the frequency of moderate and severe episodes compared to placebo, with a mean decrease of 8.8 events per day from baseline at week four (day 29) for the ABCL635 group, versus 3.5 for the placebo group.
This yielded a mean placebo-adjusted treatment difference of 5.3.
The mean percentage reduction for frequency was 83% in those receiving ABCL635, compared with 33% in the placebo group, representing a 50% mean placebo-adjusted treatment difference.
Severity scores also decreased, with a mean reduction of 1.4 points in the treatment group compared to 0.3 in placebo, and a placebo-adjusted difference of 1.1.
The study also reported improvement in sleep scores and patient global impression of change among recipients of ABCL635.
The treatment was well-tolerated, with no reported serious or severe adverse events, nor any cases leading to discontinuation. The most common adverse events were headache, fatigue, and reaction at the injection site.
AbCellera chief medical officer Sarah Noonberg said: “These positive results represent a significant milestone for women’s health and for AbCellera. By successfully targeting the NK3 receptor with an antibody, we have demonstrated potential best-in-class vasomotor symptom relief over four weeks with a single subcutaneous dose.
“These data indicate that ABCL635 could offer menopausal women a well-tolerated, long-acting treatment that has the potential to markedly improve their quality of life.”
The ongoing Phase II study continues to assess the safety and efficacy of ABCL635 in postmenopausal women with VMSM-S due to menopause.
