Zealand Pharma Announces Presentation of Preclinical Data on Amylin Analogue, ZP8396, and Clinical Data on Glucagon-GLP1 Dual-Agonist, BI 456906, at The Obesity Society Annual Meeting

Rhea-AI Summary

Zealand Pharma presents promising preclinical data for its amylin analogue ZP8396 and clinical data for BI 456906, a glucagon-GLP1 dual-agonist, at the Obesity Society Annual Meeting. The preclinical results indicate up to 20% weight loss in in vivo models when ZP8396 is combined with semaglutide. Meanwhile, BI 456906 demonstrated clinically relevant body weight reductions of up to 13.7% over 16 weeks in a Phase 1 trial. Both compounds showcase Zealand's innovative pipeline aimed at treating obesity, with further studies planned.

Positive

• Preclinical data shows ZP8396 can achieve up to 20% weight loss when combined with semaglutide.
• BI 456906's Phase 1 trial resulted in bodyweight reductions of up to 13.7% after 16 weeks.
• Both drugs reflect progress in Zealand's pipeline for obesity treatments.

Negative

• None.

Company announcement – No. 63 / 2021

Zealand Pharma Announces Presentation of Preclinical Data on Amylin Analogue, ZP8396, and Clinical Data on Glucagon-GLP1 Dual-Agonist, BI 456906, at The Obesity Society Annual Meeting

• Preclinical data showed anti-obesity effects of amylin analogue ZP8396 in in vivo models, with up to 20% weight loss when combined with GLP1 analogue semaglutide.
  
  
• In a Phase 1b dose escalation trial, BI 456906 for obesity was generally well tolerated and resulted in clinically relevant bodyweight reductions of up to 13.7% after 16 weeks.
  
  

Copenhagen, DK and Boston, MA, U.S. November 1, 2021 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078,) a biotechnology company focused on the discovery, development and commercialization of innovative peptide-based medicines, today announced it will present preclinical data from its amylin analogue, ZP8396 at the Obesity Society Annual Meeting, to be held virtually during ObesityWeek® Interactive, an online conference taking place in the week of November 1-5, 2021. This is the first time that data on this investigational candidate will be presented at a medical meeting. Additionally, Boehringer Ingelheim will present the first clinical data on the glucagon receptor (GCGR)/Glucagon-like peptide-1 receptor (GLP1R) dual agonist BI 456906 for the treatment of obesity, a compound that was in-licensed from Zealand Pharma.

“We are excited to debut preclinical data on our amylin analog, ZP8396, which holds potential as a treatment option in obesity both as a monotherapy and in combination with other drugs. When administered in combination with semaglutide, up to 20% weight loss in in vivo models was observed, which supports the initiation of a Phase 1 clinical study planned for later this quarter,” said Adam Steensberg, Executive Vice President and Chief Medical Officer at Zealand Pharma. “We are also thrilled to see Boehringer Ingelheim presenting the first clinical data on BI 456906, a GCGR/GLP1R dual agonist, where clinical data showed up to 13.7% weight loss following 16 weeks dosing in individuals with overweight/obesity and no unexpected safety issues were observed. The early data generated from these two programs highlight the potential of our growing investigational pipeline in obesity, an area in which we are committed to pioneering the development of novel treatments.”

Presentation Details

Poster Title: Potent Anti-obesity Effects of Amylin Analogue ZP8396 in Combination with Semaglutide in DIO Rats

Author: Jolanta Skarbaliene, PhD, Principal Scientist, Zealand Pharma A/S

Poster Viewing Reception Date and Time: November 1-5, 2021 with continued access through December 31, 2021

Poster Number: 372

Poster Title: Phase I Study of Glucagon-like Peptide-1/Glucagon Receptor Dual Agonist BI 456906 in Obesity

Author: Jorge Arrubla, MD, PhD, Scientific Study Advisor/ Executive Assistant, Profil Institut für Stoffwechselforschung GmbH

Poster Viewing Reception Date and Time: November 1-5, 2021 with continued access through December 31, 2021

Poster Number: 231

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About ZP8396
ZP8396 is a potent long-acting amylin analogue designed to improve solubility, minimize fibrillation and allow for co-formulation with other peptides, including GLP1 analogues. Amylin analogues hold potential as both mono and combination therapies for obesity. In preclinical studies, ZP8396 has shown potent anti-obesity effects and Zealand plans to initiate a Phase 1 trial in 2021.

About BI 456906
The BI 456906 GCGR/GLP1 dual agonist is being investigated for the treatment of obesity, NASH and type 2 diabetes. GLP1 agonism is expected to lower body weight and provide glucose control. GCGR agonism is expected to lower body weight and lead to improvement in NASH. The compound leverages the known effects of the natural gut hormone oxyntomodulin, which has been shown to decrease food intake and increase energy expenditure in humans as well as the established effects of GLP1 agonism on both glucose control and body weight.

About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, development, and commercialization of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s robust pipeline of investigational medicines includes three candidates in late-stage development. Zealand markets V-Go®, a basal-bolus insulin delivery option for people with diabetes and has received FDA approval for Zegalogue® (dasiglucagon) injection, the first and only glucagon analogue for the treatment severe hypoglycemia in pediatric and adult patients with diabetes aged 6 and above. License collaborations with Boehringer Ingelheim and Alexion Pharmaceuticals create opportunity for more patients to potentially benefit from Zealand-invented peptide investigational agents currently in development.

Zealand was founded in 1998 in Copenhagen, Denmark, and has presence throughout the U.S. that includes key locations in New York, Boston, and Marlborough (MA). For more information about Zealand’s business and activities, please visit http://www.zealandpharma.com.

Forward-Looking Statement
This press release contains “forward-looking statements”, as that terms is defined in the Private Securities Litigation Reform Act of 1995, as amended, 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 labeling; failure to obtain regulatory approvals in other jurisdictions; product liability claims; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. 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 press release and are based on information available to Zealand Pharma as of the date of this release. 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.

For further information, please contact:

Zealand Pharma Investor Relations

Maeve Conneighton

Argot Partners

investors@zealandpharma.com

Zealand Pharma Media Relations

David Rosen

Argot Partners

media@zealandpharma.com

FAQ

What are the results of the ZP8396 amylin analogue presented by Zealand?

Preclinical data reveals ZP8396 induces up to 20% weight loss when combined with semaglutide.

What were the outcomes of the BI 456906 trial?

In a Phase 1 trial, BI 456906 led to bodyweight reductions of up to 13.7% after 16 weeks.

When is Zealand planning to initiate further studies on ZP8396?

Zealand plans to initiate a Phase 1 clinical study for ZP8396 later in the quarter.

Where is Zealand Pharma presenting its data?

Zealand is presenting its data at the Obesity Society Annual Meeting during ObesityWeek® Interactive.

What is the significance of the data for investors in ZEAL?

The positive preclinical and clinical results underscore Zealand's potential for growth in the obesity treatment market.