AbbVie’s Amylin Candidate ‘Competitive’ in Early-Stage Trial

 

AbbVie’s foray into the obesity space is successful so far, analysts agree, as amylin analog ABBV-295 elicited as much as 9.73% weight loss at 13 weeks in the multiple ascending dose portion of a Phase 1 trial.

AbbVie continues to insist that it is more than an immunology and inflammation and neuroscience company. On Monday, the Illinois-based pharma reported top-line results from an early study of its weight loss contender ABBV-295 that BMO Capital Markets analysts say “paint a path” for AbbVie to compete in obesity.

Results from the multiple ascending dose (MAD) portion of a Phase 1 study of ABBV-295 showed weight reduction of 7.75% to 9.79% at 12 weeks and 7.86% to 9.73% at 13 weeks, according to AbbVie’s Monday press release.

“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,” BMO added in a note to investors.

ABBV-295 also demonstrated a favorable tolerability profile at all evaluated dose levels, according to AbbVie’s announcement, and no serious adverse events (AEs) were reported. The most commonly reported AEs were gastrointestinal disorders, which the company stated were mostly mild and primarily occurred during the first six weeks of treatment.

The MAD portion of the study enrolled 76 participants, of whom 88.3% were male. The long-acting amylin analog was dosed every other week and monthly after week 5. Different dose levels—between 2 mg and 14 mg—were tested.

“Differences in the baseline BMI and male enrollment in each of the study populations make comparisons to other assets like Lilly’s eloralintide more challenging,” BMO said, “but efficacy even at extended dosing intervals for ABBV-295 is encouraging.”

In a Phase 1 proof-of-concept study, weight loss generated by Lilly’s amylin agonist eloralintide ranged from 2.6% to 11.3% at 12 weeks.

“[W]e believe the week 12 weight loss of roughly 10% is competitive across the amylin class, and therefore is an encouraging initial update,” William Blair analysts wrote to investors Monday morning.

Phase 1 data for ABBV-295 “support continued development” of the asset, AbbVie said Monday. Eloralintide achieved weight loss of 20% in a mid-stage study in November 2025, a target AbbVie will be eager to match as it progresses through clinical trials.

It will be a long road to market, however, RBC Capital Markets said in its own Monday note, predicting a “2030 timeframe.” Nevertheless, the analysts said the new 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.”

https://www.biospace.com/drug-development/abbvies-amylin-candidate-competitive-in-early-stage-trial