TE-8105 Receives Australian HREC Approval and Officially Enters Phase 2b Clinical Development — Advancing to the Next Stage of Clinical Efficacy and Dosing Strategy Evaluation

T-E Pharma’s subsidiary, Immunwork, Inc., announced that its proprietary ultralong-acting GLP-1 receptor agonist (GLP-1 RA), TE-8105, has received approval from an Australian Human Research Ethics Committee (HREC), officially enabling the initiation of its Phase 2b clinical trial. This milestone marks an important step forward in Immunwork’s development of long-acting peptide therapeutics and represents TE-8105’s transition from the safety and pharmacological assessment conducted in the Phase 1/2a first-in-human study to a larger-scale evaluation of clinical efficacy, safety, tolerability, and dosing strategies. TE-8105 is developed using Immunwork’s proprietary Fatty Acid Bundle Platform, which conjugates a modified GLP-1 peptide with a fatty acid bundle containing two long-chain fatty acids. By enhancing albumin binding, the technology is designed to extend the drug’s duration of action in the human body, with the potential to reduce dosing frequency. TE-8105 is currently being developed primarily for the treatment of obesity and weight management, while its potential applications in type 2 diabetes, steatohepatitis, and other metabolic diseases are also being explored. Phase 1/2a First-in-Human Study Completed, Establishing a Clinical Development Foundation The Phase 1/2a first-in-human clinical trial of TE-8105 was completed in Australia in 2025. The study demonstrated favorable safety and tolerability, with treatment-related adverse events primarily consisting of mild gastrointestinal symptoms commonly associated with GLP-1 therapies. No serious adverse events related to the drug were observed. In addition, participants showed favorable trends in body weight, BMI, HbA1c, waist-to-hip ratio, and other metabolic parameters. Some participants achieved clinically meaningful weight loss within four months with fewer than nine doses, demonstrating the preliminary therapeutic potential of TE-8105 for obesity treatment. Furthermore, the results of the TE-8105 first-in-human study were published in the international journal Journal of Clinical Pharmacology in July 2026, and the study was also selected for presentation at the 20th World Congress of Basic and Clinical Pharmacology (WCP2026). These achievements further strengthen the scientific evidence supporting the clinical development of TE-8105 and enhance its visibility in the global clinical pharmacology and drug development communities. Phase 2b Clinical Trial Officially Initiated, Focusing on Dosing Strategy and Efficacy Evaluation While the Phase 1/2a study primarily focused on first-in-human safety, tolerability, and clinical pharmacology, the Phase 2b clinical trial will further evaluate different dosing strategies and dose regimens of TE-8105. The study is expected to enroll approximately 200 participants with obesity or overweight and will systematically assess weight-loss efficacy, safety, and tolerability. In addition to key weight-management parameters such as body weight and BMI, the trial will also evaluate changes in blood glucose, fatty liver-related parameters, and other metabolic indicators. The study is designed to further characterize the clinical profile of once-every-two-weeks (Q2W) dosing of TE-8105 and provide important data to guide the design and optimization of the dosing strategy for future Phase 3 clinical development. Expanding the Clinical Applications and Global Development Potential of TE-8105 As GLP-1 receptor agonists have become an important therapeutic class for obesity and metabolic diseases, reducing dosing frequency, improving treatment convenience, and addressing diverse patient needs have increasingly become key areas of development for long-acting GLP-1 therapies. Immunwork will continue to advance the clinical development of TE-8105, focusing on obesity and weight management while further evaluating its potential applications in type 2 diabetes, steatohepatitis, obstructive sleep apnea, and other metabolic diseases. At the same time, the company will actively pursue international collaboration opportunities through licensing, co-development, and other strategic partnership models, with the goal of advancing the global clinical development and future commercialization of TE-8105.

The release as fetched from its publisher. immunwork.com ↗