BLX 7006 / Biolexis Therap - LARVOL DELTA

Combination Effect of Oral GLP-1R Agonist BLX-7006 and a Oral γ3-Selective AMPK Activator BLX-0871 (OBESITY WEEK 2025) - "The combination of the oral GLP-1RA BLX-7006 and the γ3-selective AMPK activator BLX-0871 provides a compelling, mechanistically rational dualtherapy. This strategy not only improves glycemic control and enhances weight loss but also critically mitigates muscle atrophy, a key concern in obesity therapeutics.These powerful preclinical results have provided a direct rationale for clinical translation; accordingly, both BLX-7006 and BLX-0871 have advanced into Phase 1clinical trials as of Q3 2025. This tissue-selective, dual-pathway approach represents a promising next-generation strategy to treat metabolic disease more effectivelyand durably."

Diabetes • Genetic Disorders • Metabolic Disorders • Muscular Atrophy • Obesity • Type 2 Diabetes Mellitus

A Research Study to Evaluate BLX-7006 in Healthy Adults (clinicaltrials.gov) - P1 | N=76 | Not yet recruiting | Sponsor: Biolexis Therapeutics

New P1 trial

Biolexis Therapeutics Advances Breakthrough GLP-1 and AMPK Programs into First-in-Human Clinical Trials (PRNewswire) - "Biolexis Therapeutics, Inc...today announced the initiation of Phase I clinical trials for its lead GLP-1 and AMPK small molecule programs. These trials, scheduled to begin this August in Australia, represent a major inflection point in Biolexis' mission to redefine the treatment landscape for obesity, metabolic dysfunction, and muscle degeneration....In preclinical studies, Biolexis' oral GLP-1 receptor agonist, BLX-7006, resulted in a 29% reduction in weight in diet induced obesity mice. In GLP toxicology studies, BLX-7006 demonstrated no observed adverse events in both Sprague Dawley Rats and Cyno Non-human Primates, supporting a wide therapeutic window and a clean safety profile....Vankayalapati also noted a Phase I study combining BLX-7006 and BLX-0871 is slated to begin during the second quarter of 2026."

New P1 trial • Preclinical • Obesity

Biolexis Therapeutics Unlocks a New Frontier in GLP-1 Receptor Activation (PRNewswire) - "Biolexis Therapeutics has achieved a transformative milestone in metabolic drug discovery with the successful resolution of the cryo-electron microscopy (cryoEM) structure of BLX-7006, its first-in-class oral small-molecule GLP-1 receptor agonist. This breakthrough confirms a completely novel allosteric activation mechanism for the GLP-1 receptor, distinct from any previously known approaches...Biolexis is actively completing the toxicology and manufacturing studies necessary to support human clinical testing of BLX-7006. With these critical studies underway, the company plans to initiate first-in-human trials in Q3 2025, marking a major step toward bringing this novel therapy to patients with obesity, type 2 diabetes, and metabolic dysfunction."

New trial • Preclinical • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Biolexis Therapeutics Announces Positive Results from Expanded Diet Induced Obesity (DIO) Model Study for BLX-7006 (PRNewswire) - "Biolexis Therapeutics...today announced the successful completion of an expanded diet-induced obesity (DIO) trial for its candidate drug, BLX-7006. The results demonstrate significant weight loss and superior efficacy compared to leading obesity therapies, including Semaglutide and Orforglipron, providing robust support for BLX-7006's potential as a transformative treatment for obesity & diabetic indications. The newly completed study builds upon a previous DIO study in which BLX-7006 demonstrated a promising 15.6 % weight loss. In the expanded study, BLX-7006 achieved a substantial 29% weight loss, attributed to evaluating higher dosage levels. These higher doses were well tolerated, with no observed toxicity, marking an important milestone in the development of BLX-7006 for obesity management."

Preclinical • Diabetes • Metabolic Disorders

Novel Oral Small Molecule GLP1 Agonist Reduces Body Weight and Improves Glucose Control in DIO Mice (OBESITY WEEK 2024) - "Six groups, 10 mice per group were (vehicle, 3 dose levels of MLX-7006, Semaglutide and Orforglipron) dosed daily for 4 weeks. The novel, orally available small molecule GLP-1 agonist, MLX-7006, demonstrated significant and robust reductions in body weight and improved glucose homeostasis in DIO mice. These findings highlight the potential of MLX-7006 as a promising treatment for obesity and type 2 diabetes. Further preclinical investigations to characterize MLX-7006 in obesity models and studies on its general toxicology, safety, and tolerability are underway."

Preclinical • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Biolexis Therapeutics to Present Two Groundbreaking Abstracts at Upcoming Scientific Conference (PRNewswire) - "Biolexis...is proud to announce the presentation of two significant abstracts at the upcoming American Diabetes Association conference on June 21-24, 2024....The first abstract, 1139-P, details the discovery of MLX-7006, a potent and orally efficacious small molecule agonist of the GLP-1 receptor. This groundbreaking compound demonstrates significant potential in the treatment of metabolic disorders, offering a new avenue for therapeutic intervention. The second abstract, 1145-P, focuses on MLX-0871, an isoform-selective, orally available AMPK activator. This compound has shown remarkable efficacy in preclinical models of obesity and type 2 diabetes, highlighting its promise as a novel treatment for these widespread conditions."

New molecule • Preclinical • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Biolexis Therapeutics launches subsidiary Metabolexis to develop novel oral medicines for Obesity and Type 2 Diabetes to improve human longevity (PRNewswire) - "Biolexis Therapeutics...today announced the launch of Metabolexis, a new pipeline company developing three targeted oral small molecules for the treatment of Obesity and Type 2 Diabetes, with the potential to improve human Longevity....The Metabolexis pipeline includes isoform-specific activators of AMPK, aGLP-1/GLP-1R agonists, and mTORC1 inhibitors with plans to file Investigational New Drug Applications (INDs) for all three agents by the end of Q4 2024 and to initiate First-In-Human Phase I safety clinical trials in Q1 2025."

IND • New P1 trial • Pipeline update • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus