• 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 I March 28, 2023 I 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.

About 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.

SOURCE: Zealand Pharma