Pharma Focus Europe

Zealand Pharma Reports Encouraging Findings From Phase 1 Trial of Multiple Ascending Dose With Amylin Analog ZP8396

Monday, July 03, 2023

Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company specializing in the development of innovative peptide-based medicines, has announced the results of Part 1 of a multiple ascending dose (MAD) trial for ZP8396. This compound is a long-acting amylin analog with potential applications in the management of overweight and obesity. The primary objective of Part 1 was to evaluate the safety, tolerability, and clinical effects of six weeks of treatment with ZP8396 in both lean and overweight individuals.

The findings from Part 1 of the MAD trial are encouraging. The study enrolled 20 participants with a median BMI of 25 (kg/m2), who were randomly assigned to receive subcutaneous injections of ZP8396 or a placebo in two dose cohorts. Following six once-weekly doses of 0.6 mg and 1.2 mg ZP8396, the mean reductions in body weight from baseline were 5.3% and 5.1%, respectively. In comparison, the placebo group exhibited a modest decrease in body weight of 0.4%.

The tolerability profile of ZP8396 was favorable, with no reports of serious or severe adverse events, and no participants withdrew from the trial. The most common adverse events were mild and related to the gastrointestinal system, occurring predominantly within two days of the initial dose. Based on these positive results, Zealand Pharma has initiated Part 2 of the trial, which will involve 16 weeks of dosing with higher exposure levels of ZP8396. Detailed results from the six-week Part 1 will be presented at a scientific conference later this year, while the topline results from the 16-week Part 2 are expected in 2024.

The MAD trial is a randomized, double-blind, placebo-controlled clinical trial conducted at a single center. It includes both normal weight and overweight individuals who are otherwise healthy. The trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of ZP8396. Part 1 comprised 20 participants who received six once-weekly doses, while Part 2 will enroll 48 participants and administer 16 once-weekly doses using a dose up-titration scheme.

ZP8396 is an investigational long-acting amylin analog designed to enhance solubility, minimize fibrillation, and enable co-formulation with other peptides, including GLP-1 analogs. Amylin analogs have potential applications as standalone treatments or in combination therapies for obesity. Preclinical models of obesity and diabetes have demonstrated that ZP8396 can reduce body weight and improve glycemia. The SAD trial showed consistent and sustained reductions in body weight, with up to 4.2% reduction from baseline (4.8% placebo-corrected) after a single 2.4 mg dose of ZP8396. The trial also indicated good tolerability, with no severe adverse events or withdrawals reported. The most frequent related adverse events included decreased appetite, early satiety, nausea, and vomiting, which were mostly mild and transient. No anti-drug antibodies were detected, and the pharmacokinetic profile supported once-weekly dosing, with a plasma half-life of approximately 10 days. These findings were presented at the American Diabetes Association's Scientific Sessions in June 2023.

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