ALV-100 / Alveus Therapeutics, Gmax Biopharm, Sino Biopharm - LARVOL DELTA

PRESERVE: Study to Assess the Effect and Safety of ALV-100 on Maintenance of Weight Loss (clinicaltrials.gov) - P2 | N=220 | Recruiting | Sponsor: Alveus Therapeutics, Inc.

New P2 trial • Genetic Disorders • Obesity

Alveus Therapeutics Announces FDA Clearance of IND and First Patient Dosed in Phase 1b Trial of ALV-100 for Obesity (The Manila Times) - "The first patient was dosed last week...Approximately 180 patients will be enrolled across multiple U.S. clinical sites....'This Phase 1b study is the first of several planned milestones as we move toward Phase 3 readiness in the second half of 2027.'"

IND • New P3 trial • Trial status • Obesity

Alveus Therapeutics Launches with $160 Million Series A Financing to Advance Next-Generation Therapies for Obesity and Metabolic Diseases (GlobeNewswire) - "Financing supports Phase 2 development of ALV-100, IND filing of ALV-200 and advancement of additional programs across the R&D pipeline. ALV-100, a bifunctional GIPR antagonist / GLP-1R agonist, designed for durable weight management with improved quality of weight loss and long-term maintenance....ALV-200, a highly selective amylin receptor 3 (AMYR3) peptide agonist, has entered IND-enabling stage. Alveus’s amylin portfolio also includes small oral molecules and multifunctional formats."

Financing • Obesity

Equipped with $160M series A, Alveus debuts into crowded obesity development landscape (FierceBiotech) - "Alveus, which launched Thursday under the stewardship of former I-Mab CEO Raj Kannan, is aiming to advance an undisclosed number of obesity candidates, with the dual-acting asset ALV-100 leading its current development roster...The biotech is dabbling in both injectable and oral administration and gave special mention to ALV-200, a highly selective amylin receptor 3 (AMYR3) peptide agonist that has now entered the IND-enabling stage."

Financing • Obesity