Author: Laura Shaw

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.

CryoEM Confirms a First-in-Class Allosteric Binding Mode, Validating MolecuLern™ AI-Driven Discovery

LEHI, Utah, March 14, 2025 /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.

The cryoEM structural confirmation validates the predictive power of MolecuLern, Biolexis’ AI-enabled drug discovery platform. MolecuLern identified BLX-7006 as a novel small molecule capable of allosterically modulating GLP-1 receptor activity. Unlike many oral small-molecule GLP-1 therapies being developed—whose compounds are almost exclusively modified analogs of existing molecules such as Pfizer’s Danuglipron and Eli Lilly’s Orforglipron—BLX-7006 is a brand-new chemotype with an entirely unique binding mode.

“The cryoEM structural confirmation of BLX-7006 provides definitive proof that we have discovered a new way to activate the GLP-1 receptor allosterically,” said Dr. Hariprasad Vankayalapati, Chief Scientific Officer of Biolexis Therapeutics. “This isn’t just an incremental improvement on existing compounds—it’s a new mechanism enabled by our AI-driven approach to drug discovery. With superior metabolic stability and a more efficient synthesis process, BLX-7006 represents a breakthrough in the quest for next-generation, oral GLP-1 therapies.”

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.

Asked to provide additional details on Biolexis’ AI drug discovery platform, Vankayalapati stated, “MolecuLern integrates AI-driven molecular design, wet lab validation, and proprietary structural modeling to identify innovative small molecules for challenging drug targets. The successful cryoEM validation of BLX-7006’s novel binding mode underscores the ability of MolecuLern to accurately predict molecular interactions and accelerate the discovery of first-in-class therapeutics.”

Dec 09, 2024, 08:01 ET

Study Demonstrates 16.6 % at day 7 to 29 % on terminal day 28 Weight Loss and Superior Efficacy Compared to peptide-based approved or clinical stage oral Obesity Drugs in the DIO Model

LEHI, Utah, Dec. 9, 2024 /PRNewswire/ — Biolexis Therapeutics, a leading metabolic drug discovery company focused on improving the lives of patients with chronic metabolic conditions, including obesity, diabetes, and related diseases, 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.

“We are extremely encouraged by the results of our expanded DIO study, which show a significant improvement in weight loss with BLX-7006 compared to our initial study,” said Dr. Hariprasad Vankayalapati, Chief Scientific Officer at Biolexis Therapeutics. “The higher dosage levels are well tolerated, have yielded a 29% weight loss, which is not only a strong indication of the potential therapeutic benefits of BLX-7006, but also underscores its safety profile, with no evidence of toxicity at these elevated doses in non-clinical animal models. Our findings place BLX-7006 in a competitive position in the obesity treatment space.”

In addition to the DIO study, Biolexis has completed a non-human primate study to assess BLX-7006’s oral bioavailability profile. The study demonstrated high exposure levels, further validating BLX-7006’s potential translation into future human clinical trials. “These results are a testament to the strength of our BLX-7006 program and the dedication of our team in developing novel metabolic therapeutics,” said Keith Marmer, Chief Business Officer of Biolexis Therapeutics. “With the growing global prevalence of obesity and related metabolic disorders, there is a pressing need for more effective oral treatments over current injectables. The compelling results from both our expanded DIO study and the non-human primate study position BLX-7006 as a promising future clinical candidate to address this critical unmet need.”

Biolexis will present these findings and additional data at the upcoming Innovation in Obesity Therapeutics Summit in San Diego, CA, on December 11-12, 2024. Biolexis Co-founder Dr. David Bearss will present the latest data on BLX-7006’s efficacy and its potential to provide a safe, effective, and oral alternative for patients struggling with obesity and related metabolic conditions. “We are excited to share these groundbreaking results with the scientific community at the Innovation in Obesity Therapeutics Summit,” said Dr. Bearss. “As we continue to advance BLX-7006 through clinical development, we remain committed to improving patient outcomes and bringing innovative solutions to the market that can have a meaningful impact on the lives of those affected by chronic metabolic diseases.”

Lehi, UT – October 29, 2024 – Biolexis Therapeutics, a pioneering biopharmaceutical company focused on developing next-generation weight loss treatments, today announced the successful completion of recent pre-clinical studies for its innovative AMPK agonists. The studies highlight the potential of Biolexis’ two isoform-specific AMPK agonists, designed as oral, small molecules that selectively target skeletal muscle without affecting cardiac muscle or other tissues.

Historically, the development of AMPK agonist drugs has been fraught with challenges. Several companies have attempted to create pan-activators for AMPK, but these efforts have largely failed to yield effective or safe therapies. Biolexis Therapeutics distinguishes itself through its isoform-specific approach, focusing on the unique benefits of skeletal muscle activation, which is critical for effective weight management and metabolic health.

“Current weight loss treatments typically achieve positive weight loss, but often at the expense of muscle loss,” explained Hariprasad Vankayalapati, PhD, M. Pharm., Chief Scientific Officer of Biolexis. “We believe our unique muscle sparing AMPK treatment, particularly when combined with GLP-1 drugs, represents a new generation for the long-term treatment of obesity.”

In the recently completed studies involving type 2 diabetes (DB/DB) and diet-induced obesity (DIO) mouse models, Biolexis’ AMPK candidates demonstrated compelling efficacy. The oral glucose tolerance test conducted in the DB/DB study showcased significant regulation of blood glucose levels, with notable differences in HbA1C levels between treatment and control groups. Furthermore, the treatment group exhibited a significant decrease in fasting blood glucose levels, while the DIO study indicated a marked reduction in fed blood glucose levels.

These findings suggest that Biolexis’ AMPK assets effectively modulate blood glucose, an essential component in achieving weight loss and maintaining metabolic homeostasis. Additionally, DEXA scans from the DIO study animals revealed a reduction in fat mass while preserving relative muscle mass, further underscoring the unique advantages of the isoform-specific approach.

Looking ahead, Biolexis is set to file INDs in coming months and present data in future meetings from completed efficacy studies on their isoform specific lead AMPK activator in combination with its oral GLP-1 agonist, which has previously demonstrated a 15% weight loss as a single-agent therapy.

“This combination has the potential to enhance therapeutic outcomes for patients struggling with obesity and related metabolic conditions. At Biolexis, we are committed to redefining the landscape of weight loss treatments through innovative science and targeted therapies,” said Keith Marmer, Chief Business Officer of Biolexis Therapeutics. “Our successful pre-clinical results demonstrate the promise of our isoform-specific AMPK agonists, paving the way for future advancements that can provide effective, safe, and sustainable weight loss solutions.”

For more information about Biolexis Therapeutics and its pioneering research, please visit biolexistx.com.

Media Contact:

Kyle Medley
Director of Business Development
Email: kmedley@biolexistx.com

Lehi, UT – September 12, 2024 – Biolexis Therapeutics, a biopharmaceutical company pioneering next-generation weight loss treatments, today announced the remarkable preclinical results of its oral small molecule GLP-1 agonist, BLX-7006. In a recent study, BLX-7006 demonstrated significant weight loss efficacy, establishing it as a potential breakthrough in the global fight against obesity.

In a controlled diet-induced obesity (DIO) study conducted on mice, BLX-7006 achieved an average weight reduction of 15% over a 28-day period. These promising results are comparable to those seen with semaglutide, one of the most effective GLP-1 agonists currently available. However, BLX-7006 sets itself apart with its convenient oral administration and small molecule structure, making it a transformative prospect in weight management therapeutics.

“We are thrilled with the positive outcomes from our preclinical studies with BLX-7006,” said Dr. Hariprasad Vankayalapati, Chief Scientific Officer at Biolexis. “Our goal is to bring forward an innovative weight loss therapy that offers the same, or better, efficacy as injectable treatments but in a more convenient oral form. This is a significant step forward for patients seeking safer, more accessible treatment options.”

Key Highlights of BLX-7006:

Keith Marmer, Chief Business Officer at Biolexis, commented, “BLX-7006 represents a significant leap forward in weight loss treatment. It’s oral formulation and small molecule composition could offer patients an easier, more comfortable experience while delivering highly effective weight loss results. We’re excited to advance this promising therapy through IND-enabling studies, with human clinical trials scheduled for early 2025. Biolexis is excited to deliver a weight loss treatment that is widely accessible and significantly lower cost than what is currently available today.”

Biolexis Therapeutics is dedicated to addressing the global obesity epidemic through scientific innovation. The company continues to explore ways to deliver effective, accessible, and safe weight loss treatments to patients around the world.

For more information about Biolexis and its cutting-edge research, contact:

Kyle Medley
Director of Business Development
Email: kmedley@biolexistx.com

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