AbCellera Biologics’ investigational antibody, ABCL635, significantly reduced the frequency and severity of hot flashes in a Phase 1/2 study of post-menopausal women, according to an Aug. 11 news release. In the trial, women treated with ABCL635 experienced an average decrease of 8.8 moderate and severe hot flash episodes per day at week four compared to baseline. Those on placebo saw a mean decrease of 3.5 events per day, with the difference between groups being statistically significant.
The company reported that the severity of hot flash episodes also dropped by 58% in patients taking ABCL635 versus a 12% reduction in those receiving placebo. Additionally, sleep improved among patients who received the treatment.
BMO Capital Markets said these results could reinforce ABCL635 as a “potentially best-in-class treatment” for vasomotor symptoms—hot flashes—in post-menopausal women. The firm stated that ABCL635’s efficacy numbers “appear differentiated vs. current oral agents,” referencing Astellas’ Veozah and Bayer’s Lynkuet as comparators currently indicated for hot flashes.
BMO described this readout as “transformational for AbCellera’s business,” forecasting unadjusted worldwide peak sales of $2.3 billion for ABCL635 if approved.
Regarding safety, AbCellera noted that its asset was well-tolerated over four weeks with no serious or severe toxicities reported and no side effects leading to patient withdrawal from the trial. BMO said this safety profile could further differentiate ABCL635 from other treatments that have been limited by off-target activity and liver toxicities requiring lower dosing levels.
AbCellera’s Phase 2 trial is ongoing, with additional data expected in coming months to inform optimal dosing strategies. The company plans to meet with the Food and Drug Administration to discuss late-stage development of ABCL635.
