Zealand Pharma公布ZP9830一期MAD阳性安全性结果，但仅为早期安全/PK读出，短线催化量级不足

Press release – No. 21 / 2026
Zealand Pharma announces positive topline results from the multiple ascending dose part of Phase 1 trial with Kv1.3 ion channel blocker ZP9830
ZP9830 is a novel Kv1.3 ion channel blocker with pipeline-in-a-product opportunity across a broad range of cell-mediated autoimmune diseases
Multiple doses of ZP9830 were well tolerated with no serious or severe adverse events or dose-limiting safety findings
Development program is progressing rapidly with a Phase 1b trial in people with plaque psoriasis recently initiated, and a Phase 2 trial in an additional autoimmune disease planned for initiation in H1 2027
Copenhagen, Denmark, October 19, 2026
– Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company transforming the future of metabolic health, today announced positive Phase 1 multiple ascending dose (MAD) topline results for the company’s novel Kv1.3 ion channel blocker, ZP9830.  The MAD part of the first-in-human, single-center, randomized, double-blind, placebo-controlled Phase 1 trial was designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple doses of ZP9830 in 32 healthy male and female participants.
Multiple doses of ZP9830 were found to be safe and well tolerated in this trial with a treatment duration of 4 weeks and a safety follow-up period until day 41. No dose-limiting safety findings or other significant safety concerns were observed. All treatment-emergent adverse events (TEAEs) in participants receiving ZP9830 were non-serious and mild in severity. No clinically relevant safety findings were observed in vital signs, 12-lead electrocardiogram (ECG) recordings, physical examinations, or safety laboratory parameters.  PK parameters support continued development in trials of longer duration.
"
These results represent an encouraging milestone for ZP9830. In this multiple ascending dose part of the Phase 1 trial, ZP9830 was well tolerated and no dose limiting safety findings were observed.  The findings support continued development in studies of longer duration,
" said David Kendall, MD, Chief Medical Officer of Zealand Pharma. "
This brings us one step closer to our goal of delivering a novel immunological treatment to patients. We are excited to investigate the potential of this novel asset across multiple autoimmune and inflammatory diseases.
Our Phase 1b trial in plaque psoriasis is already under way, and the data announced today give us the confidence to expand the development program and explore an additional autoimmune disease in 2027.”
Zealand Pharma initiated a Phase 1b trial with efficacy endpoints, investigating ZP9830 in people with plaque psoriasis. The trial was initiated on the back of positive topline results from the single ascending dose (SAD) part of the combined SAD/MAD Phase 1 clinical trial with ZP9830 announced earlier this year.
About the Phase 1 trial
The first-in-human single ascending dose (SAD) /multiple ascending dose (MAD) Phase 1a trial (ClinicalTrials.gov ID: NCT06682975) was conducted in healthy male/male and female participants to investigate the effects of single or multiple ascending doses of ZP9830 administered subcutaneously, as well as a single dose intravenously at one dose level. The main objectives were to assess safety, tolerability, and pharmacokinetics, with proof of mechanism as an additional exploratory objective. The SAD part of the trial included a suitable pharmacological model to explore immunomodulatory activity and provide early confirmation that ZP9830 affects immune cell biology as intended. The results from the SAD part of the trial were reported earlier this year. The MAD part of this Phase 1 trial is now completed. The trial continues to evaluate safety, tolerability, and pharmacokinetics of an additional single dose of ZP9830.
About ZP9830
ZP9830 is a potent and selective Kv1.3 channel blocker with the potential to treat a broad range of immune-mediated inflammatory diseases. Kv1.3 is a potassium ion channel that is selectively upregulated on effector memory T cells, which play a central role in autoimmunity and chronic inflammation through the release of pro-inflammatory cytokines that drive tissue damage.
The anti-inflammatory effects of Kv1.3 channel blockade have been demonstrated in preclinical models of immunological disorders. The selective expression of Kv1.3 on effector memory T cells makes it an attractive therapeutic target, as inhibition is expected to preserve the protective functions of the broader immune system.
About Zealand Pharma
Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health.
To date, more than ten Zealand Pharma invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization.
Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Cambridge, Massachusetts. Learn more at
www.zealandpharma.com
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Forward looking statements
This press release contains “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company’s pre-clinical and clinical trials and the reporting of data therefrom. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events, patient recruitment or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems at third party manufacturers; dependency on third parties, for instance contract research or development organizations; unexpected growth in costs and expenses; our ability to affect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this company announcement and are based on information available to Zealand Pharma as of the date of this announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.
Contacts
Eric Rojas (Investors)
Vice President, Head of Investor Relations
Zealand Pharma
Email:
erojas@zealandpharma.com
Neshat Anis Ahmadi (Investors)
Investor Relations Manager
Zealand Pharma
Email:
neahmadi@zealandpharma.com
Rachel James-Owens (Media)
Vice President, Corporate Communications & Media Relations
Zealand Pharma
Email:
rjamesowens@zealandpharma.com
Andreas Hylleberg Mølleskov (Media)
Director, External Communications
Zealand Pharma
Email:
ahylleberg@zealandpharma.com
Amber Fennell, Jessica Hodgson, Sean Leous (Media)
ICR Healthcare
Email:
ZealandPharma@icrhealthcare.com
+44 (0) 7739 658 783