Biomed Industries, Inc. has announced positive topline results from its Phase I clinical trial of NA-931, a novel, once-daily oral quadruple receptor agonist for obesity treatment. The data were presented at the International Conference on Obesity in Las Vegas, Nevada. The study showcased NA-931's potential to reduce body weight without muscle loss, offering a new approach to managing obesity.
NA-931: A Novel Approach to Weight Management
NA-931 is designed to target four key receptors: Insulin-like Growth Factor 1 (IGF-1), Glucagon-like Peptide-1 (GLP-1), Glucose-dependent Insulinotropic Polypeptide (GIP), and Glucagon receptors. This multi-targeted approach distinguishes NA-931 from existing therapies that typically focus on GLP-1 or dual receptor combinations. By including IGF-1, NA-931 aims to regulate fuel metabolism and body composition, preserving muscle mass while promoting weight loss. The modulation of glucagon secretion by IGF-1 further enhances its metabolic control benefits.
Phase I Trial Results
The Phase I trial was a randomized, double-blind, placebo-controlled study involving overweight or obese participants, including those with type 2 diabetes. The results demonstrated that NA-931 led to dose-dependent reductions in body weight. Specifically, participants experienced a clinically meaningful reduction of 6.4%, or 5.1% relative to placebo, after 28 days of treatment (p < 0.001). Importantly, the trial reported no significant gastrointestinal-related adverse events and no muscle loss, suggesting a favorable safety profile.
Key findings from the study include:
- Body Weight Reduction: Participants treated with NA-931 experienced an average weight reduction of up to 6.8%, or 5.1% compared to placebo (p < 0.001) over 28 days. During a 12-week open-label extension phase, those receiving 150 mg of NA-931 daily achieved body weight reductions of up to 12.7%, or 10.4% relative to placebo.
- Safety and Tolerability: In the 28-day trial, 86% of treatment-emergent adverse events (TEAEs) were rated as insignificant, with only mild nausea reported in 8.3% of participants at the highest dose (150 mg/day). No vomiting occurred at any dose level. During the 12-week study, mild nausea was reported in 16.6% of participants at the highest dose, with diarrhea reported in 8.3%.
- Pharmacokinetics: Data support a once-daily dosing regimen, with consistent blood levels regardless of fasting or high-fat meals, allowing flexible dosing schedules.
The Need for New Obesity Treatments
Obesity is a significant global health challenge, contributing to various comorbidities, including type 2 diabetes, cardiovascular disease, and liver disease. With over 650 million people affected worldwide, and projections estimating that over 50% of the global population will be affected by 2035, the need for effective and comprehensive treatments is critical.
Future Directions
"The Phase I results of NA-931 highlight its potential as a first-in-class oral quadruple receptor agonist for weight loss, with excellent safety and efficacy," said Dr. Lloyd L. Tran, CEO of Biomed Industries. A Phase II clinical trial of NA-931 is currently underway, with topline results expected in Q1 2025. This trial aims to further evaluate the efficacy and safety of NA-931 in a larger patient population.
