Pharma Focus Europe

Phase 1 Clinical Trial of Amylin Analog ZP8396 by Zealand Pharma Reveals Promising Results at ADA Scientific Sessions

Monday, June 26, 2023

Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on discovering and developing innovative peptide-based medicines. Recently, the company announced that the results from a Phase 1a clinical trial of their long-acting amylin analog, ZP8396, will be presented at the 2023 American Diabetes Association's 83rd Scientific Sessions. The top-line results from this trial were previously disclosed in March 2023 (Company Announcement No. 7 / 2023).

Dr. David Kendall, the Chief Medical Officer of Zealand Pharma, expressed enthusiasm about the potential of ZP8396 as a non-incretin treatment for overweight and obesity. By targeting key metabolic pathways and providing a potent satiety signal to the brain, amylin could offer an alternative approach to weight loss. In the Phase 1 study, treatment with a single dose of ZP8396 resulted in significant, dose-dependent reductions in body weight that were sustained over six weeks. The reductions in body weight were consistent across the different doses of ZP8396, with reductions of 2.6%, 3.6%, and 4.2% observed after one week for doses of 0.7 mg, 1.4 mg, and 2.4 mg, respectively. In contrast, participants in the placebo group experienced an increase in body weight over the same period.

ZP8396 has a plasma half-life of approximately 10 days, which makes it suitable for once-weekly administration. The drug was well tolerated in the Phase 1 trial, with no serious or severe adverse events reported, and no withdrawals. The most common adverse events were decreased appetite, nausea, and vomiting, which were mostly mild and transient. Nausea and vomiting were primarily observed in the higher dose groups. No anti-drug antibodies were detected.

The detailed findings of the Phase 1 trial will be presented in a late-breaking poster session at the 2023 American Diabetes Association's Scientific Sessions. Zealand Pharma is currently conducting a multiple ascending dose (MAD) study of ZP8396 (NCT05613387). Part 1 of the MAD study, which involves six weeks of dosing, has completed enrollment, and results are expected to be presented at a scientific meeting later in 2023. Part 2 of the study, which includes 16 weeks of dosing and explores higher doses of ZP8396, is ongoing, with topline results anticipated in 2024. Longer-duration clinical studies will be necessary to fully assess the clinical potential of ZP8396.

ZP8396 is an investigational long-acting amylin analog developed by Zealand Pharma. It has been designed to improve solubility, minimize fibrillation, and allow for co-formulation with other peptides, including GLP-1 analogs. Preclinical models of obesity and diabetes have shown promising results, demonstrating ZP8396's potential to reduce body weight and improve glycemia.

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