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Zealand Pharma steadfastly upholds amylin-based obesity drug strategy

The company has yet to secure a deal, after announcing plans to sign one with a big pharma company in August 2024. Nonetheless, CEO Adam Steensberg emphasised that Zealand is “exactly where it wants to be in the process”, on a 20 February earnings call to investors.

The delay in securing a partner comes at a time when the landscape for amylin-based therapies is mixed. Novo Nordisk’s amylin/glucagon like peptide-1 receptor agonist (GLP-1RA) combination, CagriSema (semaglutide/cagrilintide), failed to impress investors in the Phase III REDEFINE 1 trial (NCT05669755). Participants on CagriSema lost about 23% of their body weight, compared with 12% for those taking cagrilintide by itself, 16% for those on semaglutide, and 2.3% for people on a placebo. The trial met its primary endpoint but missed the mark of the 25% weight loss, which was Novo’s aim. .

Petrelintide is currently being investigated in the Phase II ZUPREME clinical trial (NCT06662539), which targets a 15% to 20% weight loss. Despite CagriSema’s results, Zealand’s chief medical officer David Kendall said that he has “great confidence” that petrelintide will meet this 15% to 20% target.

While GLP-1RAs like semaglutide work by stimulating insulin secretion, reducing glucagon levels, and slowing gastric emptying, amylin analogues such as petrelintide act through a different mechanism. By mimicking the hormone amylin, they suppress glucagon secretion, slow gastric emptying, and increase satiety. Zealand believes this distinct mode of action could position petrelintide as a best-in-class therapy in obesity and diabetes.

Zealand’s confidence in petrelintide is supported by broader investor interest in new and innovative obesity therapeutics. In June 2024, the company raised $1bn through a share offering, surpassing its original target of $900m. Earlier in January 2024, Zealand secured an additional DKr1.45bn ($204m) in funding for its obesity pipeline through a private placement and directed share issue to US investment firms. The company’s lead obesity asset, survodutide, a glucagon/GLP-1 receptor dual agonist partnered with Boehringer Ingelheim, has already advanced into Phase III trials for obesity and metabolic dysfunction-associated steatohepatitis (MASH).

Despite strong investor backing, Zealand has faced setbacks in other areas. The company’s regulatory challenges in 2024 included two US Food and Drug Administration (FDA) complete response letters (CRLs). In October, the FDA declined to approve dasiglucagon for congenital hyperinsulinism, citing the need for a reinspection of a third-party manufacturing site. In December, the agency rejected Zealand’s approval bid for glepaglutide in short bowel syndrome (SBS), recommending an additional clinical trial to establish its efficacy and safety.

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