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San Jose, CA — December 10, 2024 — Biomed Industries, Inc. (Biomed) today announced that it is presenting two research papers at the International Conference on Obesity and Chronic Diseases (ICOCD-2025) in Seattle, WA, January 2nd and 3rd, 2025
ICOCD-2025 brings together leading scientists, researchers, and research scholars, and industry experts to exchange and share their experiences and research results on all aspects of Obesity and Chronic Diseases. It also provides a premier interdisciplinary platform for researchers, practitioners and educators to present and discuss the most recent innovations, trends, and concerns as well as practical challenges and solutions adopted in the fields of Obesity and Chronic Diseases.
Phase 1 results of NA-931, a quadruple receptor agonist:
The first paper, titled “NA-931: A Novel Quadruple Agonist Targeting IGF-1, GLP-1, GIP, and Glucagon Receptors to Reduce Body Weight Without Muscle Loss”, presents the recently released top-line results from Biomed’s Phase 1B clinical trial. This randomized, double-blind, placebo-controlled study demonstrated that NA-931 achieved a clinically meaningful weight loss with no significant gastrointestinal-related adverse events or muscle loss. The findings position NA-931 as a safe and well-tolerated option for weight management.
Key differentiators of NA-931 are that it is an oral formulation, and it exhibits significantly fewer side effects compared to GLP-1-based therapies currently on the market or in development. NA-931, a small molecule quadruple receptor agonist, is being developed for the treatment of both type 2 diabetes and obesity.
Efficacy Study:
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.Phase 2- Monotherapy of NA-931 is being conducted.
A Phase 2 randomized, double-blind, placebo-controlled, 13-week study of NA-931 for weight management is being conducted in 125 patients who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition. The topline results are anticipated in the first half of 2025.
Combination Therapy of NA-931 and Tirzepatide:
The second paper, Clinical protocol of phase 2B combination therapy to assess the safety and efficacy of NA-931 alone and in combination with Tirzepatide for the treatment of obesity, provides information on Biomed’s upcoming Phase 2B clinical trial of a combination therapy with Eli Lilly’s Zepbound. The trial is intended to follow-up on Biomed’s promising preclinical studies showed that combining Tirzepatide with NA-931 resulted in synergistic effects on weight loss, blood glucose control, and lipid metabolism.
The study is designed to have three periods. The 48-week core treatment period has 9 treatment arms, with combinations of 3 Tirzepatide doses (2.5 mg and 5 mg and 15 mg injectable, weekly) and 3 NA-931 doses ( 60 mg, 120 mg and 150 mg oral, daily). The core treatment period is then followed by an open-label 12-week treatment extension period. The extension period is then followed by a 12-week post-treatment period, during which all study treatments will be withdrawn from all arms.
Combination therapies have long been a cornerstone in advancing treatments across various medical fields, and obesity management is no exception. Biomed Industries is exploring a novel therapeutic strategy by combining Tirzepatide, an FDA-approved dual GIP and GLP-1 receptor agonist marketed as Zepbound™, with NA-931, a proprietary quadruple agonist targeting IGF-1, GLP-1, GIP, and glucagon receptors. This innovative approach leverages the unique mechanisms of action of both compounds, aiming to provide superior weight loss outcomes while minimizing potential side effects.
Tirzepatide has demonstrated significant efficacy in weight reduction, but like all therapeutics, it is associated with a range of adverse events. Common side effects include nausea, vomiting, diarrhea, and constipation, particularly during the initial weeks of treatment. Additionally, published data highlight a risk of more serious events such as pancreatitis, gallbladder disease, and increased heart rate. Other adverse effects include fatigue, dizziness, and potential hypoglycemia, particularly when used in patients with type 2 diabetes. The risk of these side effects can increase with higher doses of Tirzepatide, underscoring the need for strategies that enhance efficacy while reducing dosage.
Tirzepatide’s ability to enhance insulin sensitivity and suppress appetite would potentially pair effectively with NA-931’s broader receptor activation, which promotes fat metabolism while preserving muscle mass. Together, these therapies address multiple pathways in obesity pathophysiology, offering a comprehensive and multi-targeted approach to weight management.
The combination therapy of Tirzepatide and NA-931 holds significant promise in addressing these challenges. By reducing the required dosage of injectable Tirzepatide, the therapy could lower the incidence of gastrointestinal and systemic side effects while preserving its efficacy. NA-931, as an oral therapy, not only adds convenience but also contributes to effective weight management by targeting additional pathways, further reducing reliance on higher doses of Tirzepatide.
This synergistic approach not only advances therapeutic efficacy but also addresses the growing demand for individualized, patient-centered obesity management. By tailoring treatments that leverage the strengths of multiple agents, Biomed Industries aims to set a new standard in obesity care, improving both clinical outcomes and quality of life for patients.
“Our quadruple receptor agonist is a promising therapy that will provide patients with an effective oral treatment regimen and reduce the side effects of current GLP-1 drugs. “ said Dr. Lloyd Tran, Biomed’s CEO. He continued: “We believe that through a combination approach, dosage levels of injectable GLP-1 drugs can be reduced, thereby reducing side effects, as well as provide enhanced weight loss. These developments represent a major step forward for patients.”
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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