Zealand Pharma Announces First Subject Dosed in Phase 1 Trial of Amylin Analogue ZP8396 for the Treatment of Obesity

Company announcement – No. 65/ 2021

Zealand Pharma Announces First Subject Dosed in Phase 1 Trial of Amylin Analogue ZP8396 for the Treatment of Obesity

• Preclinical data have shown potent anti-obesity effects of ZP8396 both as a monotherapy and in combination with a GLP1 analogue.
  
  
  
  

Copenhagen, DK and Boston, MA, U.S. November 4, 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 that the first patient has been dosed in a Phase 1 clinical trial evaluating the amylin analogue, ZP8396 as a potential treatment option in obesity. The study is a single ascending, dose-escalation, safety and tolerability trial in healthy volunteers.

“ZP8396 holds potential as a novel treatment option for obesity both as a monotherapy and in combination with other weight loss drugs, and the initiation of the Phase 1 clinical trial with ZP8396 is an important milestone for Zealand Pharma,” said Adam Steensberg, Executive Vice President and Chief Medical Officer at Zealand Pharma. “We remain committed to utilizing our innovative peptide platform to develop medicines with the aim of addressing unmet needs for people with obesity and associated metabolic conditions.”

The Company recently presented preclinical data on ZP8396 at the Obesity Society Annual Meeting held online the week of November 1-5, 2021.

The Phase 1, First-In-Human, randomized, single ascending dose trial, will assess safety, tolerability, pharmacokinetics, and pharmacodynamics of ZP8396 administered to healthy subjects.

Additional information about the Phase 1 ZP8396 trial is available via  (NCT NCT05096598).

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 mono and combination therapies for obesity. In preclinical studies ZP8936 has shown potent anti-obesity effects.

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), 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 .

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

 

Zealand Pharma Media Relations

David Rosen

Argot Partners