Biolexis Therapeutics Initiates First-in-Human Clinical Trials for Novel, Oral Muscle-Sparing, Weight Loss and Type 2 Diabetes Therapies

LEHI, Utah – October 8, 2025 – Biolexis Therapeutics, a biopharmaceutical company pioneering transformative treatments for metabolic diseases, today announced the initiation of two first-in-human Phase 1 clinical trials for its lead candidates, BLX-7006 and BLX-0871. These trials, being conducted in Australia, will evaluate the safety, tolerability, and pharmacokinetics of the company’s novel, all-oral, dual-mechanism therapy. This differentiated approach is designed to deliver superior weight loss while preserving critical muscle mass.

The global obesity market is dominated by injectable GLP-1 receptor agonists that, despite their effectiveness, are associated with significant challenges, including injection burden, gastrointestinal side effects, and concerning loss of lean muscle mass intrinsic to overall weight loss. Biolexis aims to overcome these limitations with a first-in-class, synergistic oral platform.

The two clinical trials are:

• NCT07140055: A study to evaluate the oral GLP-1 receptor agonist, BLX-7006, in healthy adults.
• NCT07140081: A study to evaluate the isoform-selective AMPK activator, BLX-0871, in healthy adults.

“Initiating these clinical trials marks a pivotal moment for Biolexis and a potential paradigm shift in how we approach the management of obesity and Type 2 Diabetes,” said Hariprasad Vankayalapati, M.Pharm, PhD, co-founder and Chief Scientific Officer of Biolexis. “Current therapies often force patients to sacrifice muscle for fat loss, which can compromise long-term metabolic health. Our dual-mechanism approach, combining the novel allosteric GLP-1 agonism of BLX-7006 with the targeted, muscle-preserving AMPK activation of BLX-0871, is designed to offer a more effective and sustainable solution for patients. We are thrilled to advance these promising oral agents into the clinic.”

Biolexis is collaborating with leading Australian research partners to conduct these trials. The studies will be managed by the contract research organization Southern Star Research, with participants enrolled at Nucleus Network’s clinical research facility, and bioanalytical services provided by Crux Bio.

About Biolexis’s Dual-Mechanism Platform: The Biolexis platform combines two distinct, orally administered small molecules. BLX-7006 is a novel allosteric GLP-1 receptor agonist designed to enhance satiety and glycemic control while potentially overcoming the receptor desensitization seen with current peptide agonists. BLX-0871 is a first-in-class, isoform-selective AMPK activator that specifically targets skeletal muscle and adipose tissue to increase energy expenditure and preserve muscle mass, avoiding off-target effects that have hindered previous AMPK drug development. Preclinical data has shown this combination can achieve superior weight loss with up to 87% muscle preservation.

About Biolexis

Biolexis is a clinical-stage biopharmaceutical company dedicated to developing innovative oral therapies for metabolic diseases. By pioneering a synergistic, dual-mechanism platform that combines GLP-1 receptor agonism and targeted AMPK activation, Biolexis aims to redefine the standard of care for obesity and type 2 diabetes, focusing on high-quality, muscle-sparing weight loss to improve long-term patient outcomes.