Amylyx Selects Gubra-Discovered AMX0318 GLP-1 Antagonist For Post-Bariatric Hypoglycemia Development Advances Toward IND For Rare Disease Applications

Amylyx Pharmaceuticals has announced the selection of AMX0318, a long-acting GLP-1 receptor antagonist, as a development candidate for post-bariatric hypoglycemia (PBH) and other rare diseases. The candidate emerged from a research collaboration with Gubra A/S, a Denmark-based company focused on peptide-driven drug discovery and preclinical research services.

“We are pleased to see AMX0318 advance as a development candidate, a milestone that reflects both the strong collaboration between the Gubra and Amylyx teams and the capabilities of Gubra’s proprietary peptide drug discovery platform,” said Louise S. Dalbøge, Chief Science Officer at Gubra. “Our AI-driven streaMLine platform enables multi-parameter optimization of peptide candidates, and we are excited to see this applied successfully to AMX0318 in close collaboration with Amylyx.”

AMX0318 has undergone extensive preclinical testing, demonstrating favorable stability, solubility, potency, and in vivo pharmacokinetic, pharmacodynamic, and tolerability profiles. Based on these results, Amylyx plans to move the program into IND-enabling studies later this year, with the goal of submitting an investigational new drug application in 2027, subject to successful completion of these studies.

“We are very pleased to nominate AMX0318 as a development candidate and were highly impressed by Gubra’s proprietary and innovative process, which identified a peptide that surpassed our research target profile for a long-acting GLP-1 receptor antagonist. AMX0318 has thus far shown robust preclinical and chemical properties, including a pharmacokinetic profile that may support long-acting administration,” said Camille L. Bedrosian, MD, Chief Medical Officer at Amylyx. “We are excited about the opportunity to develop additional therapeutic possibilities for people who may benefit from inhibiting GLP-1 receptor activity, including people with PBH and other rare diseases. The GLP-1 receptor is a well-characterized biological target and one of the key regulators of glucose-insulin homeostasis.”

Under the collaboration agreement, Gubra is eligible to receive more than $50 million in development and commercialization milestone payments, along with mid-single digit royalties on global net sales. The selection and transfer of AMX0318 as a development candidate will trigger milestone payments totaling $4 million to Gubra.

Dr. Bedrosian continued, “We have strong conviction that inhibiting GLP-1 receptor activity represents an important therapeutic approach given the statistically significant data that avexitide, our investigational, first-in-class GLP-1 receptor antagonist, has generated to date. We continue to expect completion of recruitment in our pivotal Phase 3 LUCIDITY trial of avexitide in Q1 2026, with topline data expected in Q3 2026.”

Founded in 2008 and listed on NASDAQ Copenhagen, Gubra is a disease-agnostic techbio company specializing in peptide-based drug discovery and early-stage development. With around 300 employees, the company operates across biotech R&D and CRO services, generating steady cash flow while advancing high-value research programs. In the first nine months of 2025, Gubra reported revenues of approximately DKK 2.6 billion, equivalent to about EUR 350 million.