Amylyx Pharmaceuticals reveals AMX0318 nomination as extended-release GLP …

Amylyx Pharmaceuticals recently revealed that they have chosen AMX0318 as a promising development candidate after a thorough evaluation process. This long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist is being considered for potential use in treating post-bariatric hypoglycemia (PBH) and other rare conditions. The selection of AMX0318 follows a collaborative effort with Gubra A/S, a company specializing in peptide-based drug discovery and preclinical research services.

“We are delighted to put forward AMX0318 as a development candidate, as it has demonstrated strong preclinical properties and promising chemical stability. The selection of AMX0318 marks a significant milestone in our pursuit of novel treatment options for individuals who could benefit from inhibiting GLP-1 receptor activity,” stated Dr. Camille L. Bedrosian, the Chief Medical Officer at Amylyx. “The GLP-1 receptor plays a vital role in regulating glucose-insulin balance, making it an attractive target for therapeutic intervention.”

Amylyx is confident in the potential of inhibiting GLP-1 receptor activity based on the positive data gathered from avexitide, their investigational GLP-1 receptor antagonist. The ongoing Phase 3 LUCIDITY trial of avexitide is expected to have full enrollment by the first quarter of 2026, with top-line results anticipated in the third quarter of the same year.

AMX0318 has undergone comprehensive preclinical assessments to evaluate its stability, solubility, potency, pharmacokinetics, pharmacodynamics, and tolerability. Amylyx is preparing to commence investigational new drug (IND)-enabling studies later this year, with the submission of an IND targeted for 2027, subject to the successful conclusion of these preclinical studies.

Louise S. Dalbøge, Chief Science Officer at Gubra, remarked on the progress of AMX0318, highlighting the fruitful partnership between Gubra and Amylyx in advancing this candidate. Gubra’s innovative peptide drug discovery platform has played a crucial role in identifying and optimizing AMX0318, reflecting the collaborative effort between the two companies.

As part of the collaboration agreement, Gubra stands to receive over $50 million in development and commercialization milestones, along with royalties on global net sales. The selection of AMX0318 as a development candidate will trigger an immediate $4 million payment to Gubra.

Gubra, founded in 2008 in Denmark, is a disease-agnostic techbio company specializing in peptide-based drug discovery and preclinical contract research services. With around 300 employees and significant revenue growth, Gubra’s focus on early-stage drug development has positioned it as a key player in the biotechnology sector.

Amylyx Pharmaceuticals’ mission is centered on addressing diseases with urgent unmet needs through innovative therapies. The company is actively pursuing multiple investigational therapies for various neurodegenerative and endocrine disorders. For more information on Amylyx, visit their website and connect with them on social media platforms like LinkedIn.

In conclusion, Amylyx Pharmaceuticals’ nomination of AMX0318 as a development candidate represents a significant step in their quest to provide therapeutic solutions for individuals with PBH and other rare diseases. This collaboration with Gubra A/S underscores the importance of strategic partnerships in advancing novel treatment options and underscores the potential of GLP-1 receptor antagonists in addressing critical medical needs.