AbbVie reports positive topline results from a Phase 1 multiple ascending dose study of ABBV-295, a long-acting amylin analog evaluated in adults.
AbbVie (NYSE: ABBV) today announced positive topline results1 from the multiple ascending dose (MAD) part of its Phase 1 study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous ABBV-295, in adults with a mean body mass index (BMI) of less than 30 kg/m2. ABBV-295 is a long-acting amylin analog that represents a mechanistically distinct class from incretin-based therapies such as GLP-1 and GIP receptor agonists.
Study enrollment mostly comprised male participants (88.3%). Different doses (2-14 mg), titrations and dose frequencies were tested in the study. ABBV-295 was generally well tolerated across all dose levels evaluated. The most commonly reported adverse events were gastrointestinal disorders, which were mostly mild, and predominantly occurred during the first 6 weeks of treatment.1
ABBV-295 demonstrated clinically meaningful, dose-dependent reductions in body weight from baseline, over a 12-13-week treatment period. In the AbbVie-295 treated groups dose-dependent least-squares (LS) mean percentage change in body weight ranged from -7.75% to -9.79% at week 12 (for weekly dosing groups), to -7.86% to -9.73% at week 13 (for every other week dosing group and monthly dosing group after week 5), compared to -0.26% and -0.25% in the placebo group at week 12 and week 13, respectively.1
“Obesity is a complex, chronic disease that places a substantial burden on patients, healthcare systems and society, and there remains a critical need for therapies that combine efficacy with tolerability and support long-term adherence,” said Primal Kaur, M.D., senior vice president, global development of immunology, neuroscience, eye care and specialty at AbbVie. “We are encouraged by these early results for ABBV-295, which demonstrate meaningful weight loss together with a well-tolerated safety profile. These initial results further reinforce the potential of ABBV-295 as a novel therapeutic option for people living with obesity.”
Results from the single ascending doses (SAD) part and other cohorts from the MAD part of the study were announced previously. Full data from the study will be presented at a future scientific conference.
Summary of Phase 1 MAD Study Key Results1 (Percent Change from Baseline in Body Weight at Week 12 and Week 13)
| Cohorta | LS Mean (95% CI) at week 12b | LS Mean (95% CI) at week 13b |
| All Placebo | -0.26 (-1.89, 1.37) | -0.25 (-1.88, 1.38) |
| Cohort 3 (weekly dosing) | -7.75 (-9.89, -5.61) | – |
| Cohort 4 (weekly dosing) | -8.70 (-10.75, -6.65) | – |
| Cohort 5a (weekly dosing) | -9.79 (-11.99, -7.59) | – |
| Cohort 5b (every other week dosing) | -7.76 (-9.82, -5.70) | -9.73 (-11.79, -7.67) |
| Cohort 6 (monthly dosing after week 5) | -6.74 (-8.70, -4.79) | -7.86 (-9.80, -5.91) |
| a Doses from 2mg to 14mg were tested using different dose escalations and dosing frequencies. |
| b LS mean estimates were derived using a Mixed Model for Repeated Measures (MMRM). Participants were required to adhere to the dosing plan and those unable to continue treatment were withdrawn from the study with no further efficacy data collected. |
About ABBV-295
ABBV-295 is an investigational, long-acting amylin analog being developed for the treatment of obesity. It is an agonist that specifically activates amylin and calcitonin receptors. Amylin, a satiety hormone, has been identified as a potential therapeutic AbbVie target for the treatment of obesity given its role in activating signals to the brain that result in appetite suppression and the reduction of food intake, while also acting as an inhibitory signal to delay gastric emptying. ABBV-295 has not been approved by any health regulatory authority worldwide. The safety and efficacy of ABBV-295 have not been established.
About the Phase 1 GUC17-01 Study
The Phase 1 clinical trial is a two-part, single center, double-blind (within cohorts), randomized, placebo-controlled, single (Part 1) and multiple (Part 2) ascending dose study of subcutaneous ABBV-295 (GUB014295). A total of 76 participants were enrolled in the MAD study. More information on this trial can be found at https://www.clinicaltrials.gov/ (NCT06144684).
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio.
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