Zealand Pharma's ZP9830 clears Phase 1 MAD safety bar

Zealand Pharma has reported positive topline results from the multiple ascending dose (MAD) portion of its Phase 1 trial with ZP9830, a selective Kv1.3 ion channel blocker being developed for cell-mediated autoimmune diseases. The Copenhagen-listed biotech said multiple doses were safe and well tolerated in 32 healthy participants over a four-week treatment period, with no serious or severe adverse events and no dose-limiting safety findings.

All treatment-emergent adverse events in ZP9830-treated participants were non-serious and mild in severity. No clinically relevant signals were identified in vital signs, ECG recordings, physical examinations or laboratory parameters. The company said pharmacokinetic data support studies of longer duration, clearing the path for trials in patient populations.

Pipeline progression

David Kendall, chief medical officer of Zealand Pharma, said the results represent "an encouraging milestone" and that they give the company "confidence to expand the development programme and explore an additional autoimmune disease in 2027." A Phase 1b trial with efficacy endpoints in people with plaque psoriasis is already under way, initiated after positive results from the earlier single ascending dose (SAD) portion of the combined Phase 1 study. A Phase 2 trial in a second, as yet unnamed, autoimmune indication is planned for the first half of 2027.

ZP9830's mechanism centres on the selective upregulation of Kv1.3 potassium channels on effector memory T cells, the population considered central to chronic autoimmune inflammation. By blocking this channel, the compound is designed to suppress pathological immune activation while leaving the broader immune system intact, a selectivity profile that has historically attracted interest in ion channel pharmacology.

Market context

The Kv1.3 channel has been under investigation as a therapeutic target for more than two decades, but ZP9830 is among the first subcutaneously delivered small-peptide blockers to enter human trials with a broad autoimmune label strategy. Zealand Pharma's decision to pursue multiple indications from a single asset, what it calls a "pipeline-in-a-product" approach, mirrors the platform logic seen in GLP-1 development, the area in which the company has built its commercial reputation.

The autoimmune biologics market is densely contested, with established anti-TNF, anti-IL-17 and anti-IL-23 therapies dominating in conditions such as plaque psoriasis and inflammatory bowel disease. A mechanistically distinct oral or injectable small-molecule-adjacent approach targeting effector memory T cells could address patients who cycle through or fail existing biologics, though that thesis will require Phase 2 efficacy data to be substantive. The plaque psoriasis indication is a well-understood regulatory pathway and a natural first choice for proof-of-concept, given the availability of validated endpoints and an experienced clinical-trial infrastructure.

Zealand Pharma, best known for its peptide chemistry platform and its GLP-1 and amylin analogue programmes in obesity and metabolic disease, is positioning ZP9830 as a strategic extension into immunology. The company has noted it intends to announce the second Phase 2 indication before the end of 2026, which will be the next material catalyst for ZP9830 and a signal of how broadly it intends to pursue the autoimmune opportunity.