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SAN JOSE, CALIFORNIA, UNITED STATES – October 7, 2024 /EINPresswire.com/ Biomed Industries, Inc. announced positive topline results from a Phase I clinical study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of its once-daily, oral quadruple receptor agonist, NA-931, in participants with obesity, with or without type 2 diabetes.
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:
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, Chief Executive Officer of Biomed Industries, Inc. “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 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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