The Amylyx Pipeline Follow-On AMX0318, a Novel Long-Acting GLP-1 Receptor Antagonist Development Candidate Identified in Collaboration With Danish Peptide Discovery Specialist Gubra A/S (Nominated January 2026), Is Progressing Through Investigational New Drug (IND)-Enabling Studies With an IND Filing Targeted for 2027; AMX0318 Demonstrated Robust Preclinical and Chemical Properties Including a Favorable Pharmacokinetic Profile That May Support Long-Acting Administration (Extending Beyond Avexitide's Once-Daily Subcutaneous Injection Format), Strong Chemical Stability, High In Vitro Potency, In Vivo Activity and Tolerability, and High Solubility; The Follow-On Candidate Extends Amylyx's Franchise Beyond Avexitide Into a Longer-Duration Product Format That Could Address Post-Bariatric Hypoglycemia and Additional Rare Diseases
The Amylyx pipeline follow-on AMX0318, a novel long-acting GLP-1 receptor antagonist development candidate identified in collaboration with Danish peptide discovery specialist Gubra A/S (nominated January 2026), is progressing through Investigational New Drug (IND)-enabling studies with an IND filing targeted for 2027. Development context: AMX0318 was selected as a development candidate after demonstrating a favorable pharmacokinetic profile that may support long-acting administration (extending beyond avexitide's once-daily subcutaneous injection format), strong chemical stability, high in vitro potency, evidence of in vivo activity and tolerability, and high solubility. The Gubra A/S collaboration draws on Gubra's peptide discovery platform (which has also contributed to Boehringer Ingelheim's survodutide dual GLP-1/glucagon agonist for obesity) combined with Amylyx's expertise in GLP-1 receptor antagonist biology developed through the avexitide program. The follow-on candidate extends Amylyx's franchise beyond avexitide into a longer-duration product format that could address post-bariatric hypoglycemia (potentially with weekly or longer dosing) and additional rare diseases where excessive endogenous GLP-1 signaling drives disease. The long-acting profile could substantially improve adherence and quality of life for patients compared to daily subcutaneous injection, and the IND filing in 2027 would position Amylyx to begin Phase 1 human studies as avexitide is entering commercial launch.