Zealand Pharma presents data for amylin analog ZP8396 at ObesityWeek

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Zealand Pharma
Zealand Pharma

Press release – No. 13 / 2023

Zealand Pharma presents data for amylin analog ZP8396 at ObesityWeek

Copenhagen, Denmark, October 17, 2023Zealand 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

Poster-080: 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.

Poster-503: 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 (NCT05613387). 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.