AbbVie Reports Positive Results for ABBV-295 Clinical Trial

AbbVie announced positive topline results from the multiple ascending dose part of its Phase 1 study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous ABBV-295, in adults with a mean body mass index 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. Different doses, 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. ABBV-295 demonstrated clinically meaningful, dose-dependent reductions in body weight from baseline, over a 12-13-week treatment period. In the ABBV-295 treated groups dose-dependent least-squares mean percentage change in body weight ranged from -7.75% to -9.79% at week 12, to -7.86% to -9.73% at week 13, compared to -0.26% and -0.25% in the placebo group at week 12 and week 13, respectively.