Amylyx Advances AMX0318 as Long-Acting GLP-1 Receptor Antagonist for Post-Bariatric Hypoglycemia
核心洞察
Amylyx Pharmaceuticals has nominated AMX0318 (搜索), a novel long-acting GLP-1 receptor (搜索) antagonist, as a development candidate for post-bariatric hypoglycemia (搜索) and other rare diseases.
The compound was identified through collaboration with Gubra A/S using their AI-driven streaMLine platform and demonstrated robust chemical stability, strong in vitro potency, and favorable pharmacokinetic properties.
IND-enabling studies are expected to begin in 2026 with an IND submission targeted for 2027, while Amylyx continues its Phase 3 LUCIDITY trial of avexitide.
Amylyx Pharmaceuticals has selected AMX0318 (搜索), a long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist, as a development candidate for post-bariatric hypoglycemia (搜索) (PBH) and other rare diseases. The compound was identified through a research collaboration with Gubra A/S, a Danish company specializing in peptide-based drug discovery and preclinical contract research services.
Novel Therapeutic Approach for Rare Endocrine Condition
AMX0318 (搜索) represents a potential advancement in treating post-bariatric hypoglycemia (搜索), a rare condition that can occur following bariatric surgery. The compound was selected after meeting key criteria including robust chemical stability, strong in vitro potency, evidence of in vivo efficacy and tolerability, high solubility, and a favorable pharmacokinetic profile consistent with long-acting peptide administration.
"We are very pleased to nominate AMX0318 (搜索) 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 (搜索) antagonist," said Camille L. Bedrosian, MD, Chief Medical Officer at Amylyx. "AMX0318 has thus far shown robust preclinical and chemical properties, including a pharmacokinetic profile that may support long-acting administration."
AI-Driven Drug Discovery Platform
The development of AMX0318 (搜索) utilized Gubra's AI-driven streaMLine platform, which enables multi-parameter optimization of peptide candidates. Louise S. Dalb∅ge, Chief Science Officer at Gubra, noted that the milestone "reflects both the strong collaboration between the Gubra and Amylyx teams and the capabilities of Gubra's proprietary peptide drug discovery platform."
AMX0318 (搜索) has completed extensive preclinical evaluation, including stability, solubility, potency, in vivo pharmacokinetics and pharmacodynamics, and in vivo tolerability studies. The compound is designed to inhibit GLP-1 receptor (搜索) activity, which Dr. Bedrosian described as "a well-characterized biological target and one of the key regulators of glucose-insulin homeostasis."
Development Timeline and Regulatory Path
Amylyx expects to advance the AMX0318 (搜索) program into investigational new drug (IND)-enabling studies later in 2026, with an IND submission targeted for 2027, pending successful completion of these studies. This timeline positions the compound for potential clinical development as the company continues to build its pipeline of therapies for rare diseases.
The selection of AMX0318 (搜索) builds on Amylyx's existing work with GLP-1 receptor (搜索) antagonists. Dr. Bedrosian emphasized the company's "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."
Ongoing Clinical Programs
Amylyx continues to advance its lead GLP-1 receptor (搜索) antagonist, avexitide, in clinical development. The company expects to complete recruitment in its pivotal Phase 3 LUCIDITY trial of avexitide in Q1 2026, with topline data expected in Q3 2026.
Financial Terms and Partnership Structure
Under the research collaboration agreement, Gubra is eligible to receive more than $50 million in success-based development and commercialization milestones plus mid-single digit royalties on worldwide net sales. The selection and handover of AMX0318 (搜索) as a development candidate triggers milestone payments of $4 million to Gubra.
Gubra, founded in 2008 and listed on NASDAQ Copenhagen, operates as a disease-agnostic techbio company with approximately 300 employees. The company reported revenue of DKK 2.6 billion (approximately EUR 350 million) in the first nine months of 2025, demonstrating the scale of its operations across both biotech development and contract research services.