Biolexis Therapeutics Advances Breakthrough GLP-1 and AMPK Programs into First-in-Human Clinical Trials

LEHI, Utah, June 12, 2025 /PRNewswire/ -- Biolexis Therapeutics, Inc. (www.biolexistx.com), a clinical-stage therapeutics company pioneering next-generation treatments for metabolic and muscle-wasting diseases, 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.

Groundbreaking Preclinical Data Propel Clinical Milestone

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. The novel chemotype of BLX-7006 and its unique binding mode was also confirmed via Cryo-EM. This structural confirmation provides definitive proof that Biolexis has discovered a new way to activate the GLP-1 receptor allosterically compared to other compounds that are almost exclusively modified analogs of danuglipron and orforglipron.

Concurrently, the company's isoform-selective AMPK activator, BLX-0871, showed dual benefits in preclinical studies: effective weight reduction and significant preservation of lean muscle mass, addressing a critical unmet need in current obesity treatments. BLX-0871 has demonstrated a favorable safety profile in GLP toxicology studies, with no observed cardiotoxicity at high doses in Sprague Dawley Rats and Beagle Dogs, reinforcing its safety profile in clinical development.

"These results validate our belief that targeting GLP-1 and AMPK pathways—individually or synergistically—can drive meaningful clinical impact," said Dr. Hari Vankayalapati, Co-founder and Chief Scientific Officer of Biolexis. "We are excited to enter human studies and continue advancing these transformative therapies." Vankayalapati also noted a Phase I study combining BLX-7006 and BLX-0871 is slated to begin during the second quarter of 2026.

New AMPK Program Targets Aging and Muscle Regeneration

In addition to its lead candidates, Biolexis will continue development of BLX-08155, an isoform-specific AMPK activator identified for its muscle-preserving and regenerative properties. This candidate will advance as a standalone development program targeting age-related sarcopenia and post-surgical muscle recovery, two areas of expanding unmet medical need. The company anticipates BLX-08155 will be ready to enter human studies during the fourth quarter of 2026. "This expansion reflects our strategic focus on fully leveraging AMPK biology," said Vankayalapati. "BLX-08155 opens new possibilities in longevity medicine and surgical rehabilitation."

Upcoming BIO International Convention Presentation

Dr. David J. Bearss, Co-founder of Biolexis, will discuss the company's updated pipeline and clinical development strategy at the BIO International Convention in Boston on June 18, 2025, at 9:30 AM EDT. The presentation will highlight Phase I trial designs for both lead programs and provide a first look at the age-related sarcopenia program.

About Biolexis Therapeutics

Biolexis Therapeutics is a pharmaceutical company committed to developing precision medicines for metabolic and muscle-related diseases. Its pipeline includes first-in-class oral therapies that target the GLP-1 receptor and isoform-specific/selective AMPK signaling, with programs focused on obesity, metabolic dysfunction, age-related sarcopenia, and muscle regeneration. Biolexis is headquartered in Lehi, Utah.

SOURCE Biolexis Therapeutics Inc