Zealand Pharma presents data for amylin analog ZP8396 at ObesityWeek

Press release – No. 13 / 2023

Zealand Pharma presents data for amylin analog ZP8396 at ObesityWeek

Copenhagen, Denmark, October 17, 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 presentations of clinical and non-clinical results for Zealand’s amylin analog ZP8396 at the Obesity Society Annual Meeting (ObesityWeek) being held in Dallas, Texas from October 14-17, 2023. Topline results from the 6-week multiple ascending dose (MAD) clinical trial were previously reported in Company Announcement No. 27 / 2023.

“The clinical results for amylin analog ZP8396 presented at ObesityWeek support its potential as a next generation treatment for overweight and obesity that could provide weight loss comparable with GLP-1 based therapies with improved tolerability,” said David Kendall, MD, Chief Medical Officer of Zealand Pharma. “We are looking forward to sharing results from the ongoing clinical trial of ZP8396 that is evaluating higher doses and a longer 16-week treatment period.”

Presentations

: Safety, Tolerability, and Clinical Effects of ZP8396, an Amylin Analog: Multiple Ascending Dose Trial

Highlights: In this clinical trial, low doses of ZP8396 induced reductions in body weight of up to 5.3% in healthy lean and overweight participants (mean body weight of 82 kg and BMI of 25.4) over only 6 weeks of treatment. The magnitude of weight loss was comparable to that observed with other peptide based therapies recently approved or in development. ZP8396 was also observed to be safe and well tolerated in this trial. A second part of this trial with a longer treatment duration and using dose up-titration is currently exploring higher doses of ZP8396 to further assess its clinical potential for the management of overweight and obesity.

: Potent Weight Loss Effects of Amylin Analog ZP8396 in Combination with Tirzepatide in DIO Rats

Highlights: Combining ZP8396 and GLP-1/GIP dual agonist tirzepatide in a preclinical model of obesity resulted in significantly greater body weight loss compared to either treatment alone. These results support the potential of combined treatment for even greater weight reduction in people living with overweight and obesity.

About the MAD trial

The MAD trial is a single-center, randomized, double-blind, placebo-controlled clinical trial in normal weight and overweight but otherwise healthy participants, investigating safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of ZP8396 (). The MAD trial consists of Part 1 and Part 2. Part 1 includes 20 participants (eligible BMI 21.0–29.9) receiving 6 once-weekly doses of ZP8396 or placebo as subcutaneous injections. Part 2 of the trial includes 48 participants (eligible BMI 27.0–39.9) receiving 16 once-weekly doses of ZP8396 or placebo using a dose up-titration scheme.

About ZP8396

ZP8396 is an investigational, potent long-acting amylin analog designed to improve solubility, minimize fibrillation, and to allow for co-formulation with other peptides, including GLP-1 agonists. Amylin analogs hold potential as both single agents as well as 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. Results from a single ascending dose (SAD) clinical trial showed dose-dependent, consistent and well-sustained body weight reductions of up to a mean of 4.2% from baseline (4.8% placebo-corrected) after one 2.4 mg dose. ZP8396 was well tolerated in the trial, with no serious or severe adverse events (AEs) and no withdrawals. The plasma half-life was approximately 10 days, suitable for once-weekly administration. These results were presented at the American Diabetes Association’s Scientific Sessions in June 2023.

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 and partnerships with a number of blue-chip pharma companies as well as commercial partnerships for its marketed products.

Founded in 1998 and headquartered in Copenhagen, Denmark, Zealand has a team in the U.S. For more information about Zealand’s business and activities, please visit .

Forward-Looking Statements

This press release 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.

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