AbbVie announced on Mar. 9 top-line results from an early-stage clinical trial of its weight loss candidate, ABBV-295. The company reported that the drug showed a reduction in body weight ranging from 7.75% to 9.79% at 12 weeks and from 7.86% to 9.73% at 13 weeks in the multiple ascending dose portion of a Phase 1 study.
The development is significant as AbbVie seeks to expand beyond its established focus on immunology, inflammation, and neuroscience into the growing obesity treatment market.
According to AbbVie, ABBV-295 demonstrated a favorable tolerability profile across all evaluated dose levels, with no serious adverse events reported. The most common side effects were gastrointestinal disorders, which were mostly mild and occurred primarily during the first six weeks of treatment. The study enrolled 76 participants, with nearly nine out of ten being male. Dosing was administered every other week and monthly after week five, with doses ranging between 2 mg and 14 mg.
Analysts from BMO Capital Markets said in a note to investors that "data shared today for MAD portion of AbbVie’s Ph 1 study of ABBV-295 (amylin) are reflective of an opportunity for AbbVie to diversify its business beyond the I&I." They also noted that differences in baseline body mass index and male enrollment make direct comparisons with other drugs challenging but found efficacy at extended dosing intervals encouraging.
In comparison, Lilly's amylin agonist eloralintide produced weight loss between 2.6% and 11.3% at twelve weeks in a similar Phase 1 proof-of-concept study. William Blair analysts wrote Monday morning that "[W]e believe the week 12 weight loss of roughly 10% is competitive across the amylin class, and therefore is an encouraging initial update." RBC Capital Markets predicted that it could be several years before ABBV-295 reaches the market but said recent data "demonstrate, in our view, a solid profile in the amylin class where there is growing excitement for ABBV given their market-leading position in the aesthetics space and the accelerating trend towards a DTC model for obesity medications."
