Category: Uncategorized

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

Led by Clarke Capital, the New Funding Round Will Accelerate the Company’s Drug Discovery Pipeline

American Fork, UT – November 29, 2023

Biolexis, Inc., a clinical stage AI-driven drug discovery company, announced today the successful closure of a $10 million Series A funding round. The investment was led by Clarke Capital, a prominent institutional investor and alternative investment firm. 

The new funding will advance Biolexis’ development pipeline which includes a range of promising metabolic drug candidates. These drugs have the potential to tackle various metabolic disorders that affect millions of people worldwide and are linked to significant health complications such as obesity and diabetes. 

“This financial backing from Clarke Capital is a testament to the potential of our metabolic drug portfolio,” said David Bearss, CEO of Biolexis. “Our science is on point and our team is ready to tackle the unmet needs within the metabolic disorder spectrum. With Clarke Capital’s support, we’re in a strong position to accelerate our drug development pipeline and move closer to bringing our solutions to patients.” 

The Series A funding marks a significant milestone for Biolexis but also marks Clarke’s return to partner with Drs. Bearss and Vankayalapati, having been a major investor in their first company, Montigen Pharmaceuticals, a decade and a half ago before it was sold to a publicly traded company. The reteaming will allow the company to expand its operations and accelerate the clinical development of its key drug candidates. 

With the prevalence of metabolic diseases on the rise and current treatments in limited supply, the need for new and effective treatment options is more urgent than ever. 

“At Clarke Capital, we’re committed to investing in companies poised to make a significant impact on healthcare,” said James Clarke, CEO of Clarke Capital. “Biolexis’ impressive approach to addressing metabolic disorders and other treatment-resistant conditions has the potential to change lives. We are overjoyed to support their mission and look forward to seeing the results of their groundbreaking work.” 

To date, Drs. Bearss and Vankayalapati have filed more than 20 Investigational New Drugs (INDs) and have secured more than 100 patents.

About Biolexis 

Biolexis Therapeutics is a privately held clinical-stage biopharmaceutical company dedicated to developing small molecules that target unmet needs and are focused on metabolic diseases. 

About Clarke Capital 

Clarke Capital is an alternative asset investment firm with a robust portfolio of successful companies. Clarke takes a “hands on” approach when partnering with visionary entrepreneurs with an aim to create and grow high-potential, industry transformative companies.

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