Company announcement – No. 7 / 2023
Zealand Pharma Announces Positive Phase 1 Clinical Results with Amylin Analogue ZP8396
Dose-dependent body weight reductions of up to a mean of 4.2% from baseline (4.8% placebo corrected) following a single dose of ZP8396
In development as a non-incretin peptide therapy for the potential management of overweight and obesity
Copenhagen, Denmark, March 28, 2023 – Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) (CVR-no. 20045078) a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced Phase 1a results for ZP8396, the company’s amylin analogue. The first-in-human study was designed to assess safety, pharmacokinetic (PK) and pharmacodynamic effects of ZP8396 in healthy lean and overweight people.
“We are excited by the potential of amylin as an alternative, non-incretin treatment for overweight and obesity, and are very encouraged that treatment with a single dose of ZP8396 led to meaningful dose-dependent and consistent reductions in body weight in this Phase 1 study,” said David Kendall, MD, Chief Medical Officer of Zealand Pharma. “We look forward to the results from the ongoing Phase 1b study assessing multiple ascending doses of ZP8396 later this year.”
In this single ascending dose study, healthy participants with a mean BMI of 25.8 were randomized (6:2) within seven cohorts and treated with either subcutaneous ZP8396 or placebo. Dose-dependent body weight reductions of up to a mean of 4.2% from baseline were observed with ZP8396 treatment. Placebo-treated participants demonstrated a body weight increase of 0.6%. The plasma half-life of ZP8396 was 230 hours, suitable for once-weekly administration.
ZP8396 was well tolerated in this study, with no serious or severe adverse events (AEs) and no withdrawals. The most frequent AEs were decreased appetite, nausea and vomiting; most events were mild and transient. No anti-drug antibodies were detected.
Zealand Pharma expects to present the results at a future scientific conference. A Phase 1b multiple ascending dose (MAD) study of ZP8396 is ongoing and the company expects to report topline results in the second half of 2023. Additional clinical studies of longer duration will be necessary to fully assess the clinical potential of ZP8396.
ZP8396 is an investigational, potent long-acting amylin analogue designed to improve solubility, minimize fibrillation and allow for co-formulation with other peptides, including GLP-1 analogues. Amylin analogues hold potential as both single agents and combination therapies for the treatment of obesity. ZP8936 has demonstrated the potential to reduce body weight and improve glycemia in preclinical models of obesity and diabetes. ZP8936 is currently being evaluated in a Phase 1b clinical trial.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with several pharma companies as well as commercial partnerships for its marketed products.
Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. that includes Boston. For more information about Zealand’s business and activities, please visit www.zealandpharma.com.
This company announcement contains forward-looking statements that provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products. 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, the occurrence of adverse safety events; risks of unexpected costs or delays; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; 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 fail to approve or may delay approval of our drug candidates or expansion of product labelling; failure to obtain regulatory approvals in other jurisdictions; and product liability claims. 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.
Anna Krassowska, PhD
Vice President, Investor Relations & Corporate Communications