NEWS

SAN JOSE, CALIFORNIA, UNITED STATES—November 4, 2024 /EINPresswire.com/ - Biomed Industries, Inc., a leading biopharmaceutical company, presented positive topline results from a Phase I clinical study of its once-daily, oral quadruple receptor agonist, NA-931, in participants with obesity, with or without type 2 diabetes.

Dr. Lloyd L. Tran, CEO of Biomed Industries, presented a talk titled "NA-931: A Novel Quadruple IGF-1, GLP-1, GIP, and Glucagon Receptor Agonist Reduces Body Weight Without Muscle Loss" at the World Obesity and Weight Management Congress which was held in Baltimore, Maryland on October 24-26, 2024.

The study demonstrated that NA-931 achieved a clinically meaningful weight loss of -6.4% or 5.1% relative to placebo after 28 days of treatment (p < 0.001). Importantly, NA-931 showed no significant gastrointestinal-related adverse events and no muscle loss, positioning it as a well-tolerated and promising option for weight management.

Study Highlights:

Body Weight Reduction:

The Phase I trial was a randomized, double-blind, placebo-controlled study conducted in participants who were overweight or obese, including those with type 2 diabetes. NA-931, a small molecule quadruple receptor agonist, is being developed for the treatment of both type 2 diabetes and obesity.

Results from the 28-day multiple ascending dose (MAD) study showed dose-dependent reductions in body weight. Participants treated with NA-931 experienced mean weight reductions of up to 6.8% , or 5.1% relative to placebo (p < 0.001).

Following this 28-day period, participants entered an 8-week open-label extension, extending the total treatment duration to 12 weeks. During this 12-week MAD study, participants receiving 150 mg of NA-931 daily achieved a body weight reduction of up to 12.7%, or 10.4% relative to placebo.

Safety and Tolerability:

28-Day Study:

NA-931 was well tolerated, with all reported treatment-emergent adverse events (TEAEs) rated as insignificant or mild. Of these, 86% were considered insignificant. Mild nausea was reported in 8.3% (1 of 12) of participants at the highest dose (150 mg/day) and in 3.7% (2 of 54) of participants overall. No vomiting occurred, even at the highest dose of 150 mg/day. Diarrhea was reported in 8.3% (1 of 12) of participants at the highest dose, and in 3.7% (1 of 54) of participants overall.

12-Week Study:

During the 12-week study, 78% of TEAEs were insignificant or mild. Mild nausea was reported in 16.6% (2 of 12) of participants at the highest dose and 6.8% (3 of 44) of participants overall. No vomiting occurred, and diarrhea was reported in 8.3% (1 of 12) of participants at the highest dose, and in 4.5% (2 of 44) of participants overall.

Pharmacokinetic Profile:

Pharmacokinetic data supports a once-daily dosing regimen for NA-931. Blood levels of the drug remained consistent regardless of fasting or after a high-fat meal, suggesting that NA-931 can be taken without regard to meal timing, offering greater flexibility for patients.

Conclusion and Next Steps:

Unlike many existing therapies, NA-931not only promotes weight loss but also preserves muscle mass, while showing a lower incidence of adverse effects typically associated with current obesity treatments.

The quadruple action mechanism of NA-931 harnesses the combined effects of Insulin-like Growth Factor 1 (IGF-1), which plays a pivotal role in fuel metabolism and body composition regulation. The additional roles of GIP, GLP-1, and Glucagon make NA-931 effective in promoting weight loss, particularly in non-diabetic patients with obesity, when used alongside diet and exercise. Furthermore, IGF-1 helps modulate glucagon secretion by inhibiting low glucose-induced glucagon expression, adding another layer of metabolic control.

The Phase I study results indicate that NA-931 not only holds promise for weight loss but also for glycemic control in individuals with type 2 diabetes. “The Phase 1 results underscore the potential of NA-931 as a first-in-class oral quadruple receptor agonist, with promising efficacy and safety.” said Dr. Lloyd L. Tran. “We believe NA-931, with its excellent safety profile, could represent a valuable treatment option for patients with obesity.”

Biomed Industries plans to present the full study data at an upcoming medical conference. A Phase 2 clinical trial of NA-931 for obesity treatment is currently underway, with topline results expected in the first quarter of 2025.

The Growing Need for Obesity Treatment:

Obesity, a chronic disease affecting approximately 650 million people worldwide, is characterized by excess adiposity that impairs health and results from a complex interplay of genetic, behavioral, and social factors. Current treatments often target only a subset of obesity's underlying causes, leaving room for improved, multi-faceted approaches.

Obesity is one of the most urgent global health challenges, associated with comorbidities such as type 2 diabetes, cardiovascular disease, liver disease, and chronic kidney disease. By 2035, over 50% of the global population—more than four billion people—are expected to be affected by obesity or overweight.

About the NA-931 Study:

The NA-931-050 trial is a Phase I randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of NA-931 in otherwise healthy adults who are overweight or obese, with or without type 2 diabetes. The full clinical protocol is available at ClinicalTrials.gov (ID: NCT06615700).

About Biomed Industries, Inc.:

Biomed Industries, Inc. is a pioneering biopharmaceutical company dedicated to developing and commercializing novel drug therapeutics to address unmet medical needs. The company's research team has developed a new platform of drugs targeting Alzheimer's disease, ALS, Major Depressive Disorder (MDD), Diabetes, Obesity, Metabolic dysfunction-associated Steatohepatitis (MASH), and rare diseases, including Rett Syndrome.

For further information, please visit Biomed Industries' official website: https://www.biomedind.com

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