Zealand Pharma’s amylin analogue weight loss candidate petrelintide helped patients lose a mean 8.6% of their body weight in a Phase 1b trial, meeting executives’ early goals and setting the stage for a mid-stage trial.
The Danish biotech is looking to rival the efficacy of popular GLP-1 receptor agonists for weight loss, but with fewer side effects. Petrelintide was well-tolerated in Phase 1b, with no reported serious or severe adverse events. The drug also helped patients in a high-dose group lose a significant portion of their body weight over 16 weeks, compared to placebo patients who lost a mean 1.7% from baseline, Zealand announced.
Jefferies analysts predicted earlier this month that petrelintide’s peak sales could reach $10 billion. Zealand’s stock {$ZEAL.CO} was up more than 9% on Thursday afternoon.
While these data are only an interim cut, they fall into a target range that Chief Medical Officer David Kendall previously said would be consistent with other amylin agonists. Kendall said on the company’s first-quarter earnings call last month that he hoped to see a 7% to 9% mean weight reduction, according to an AlphaSense transcript.
“The 16-week data further increases our confidence that with Phase 2 and 3 trials of longer duration, we will achieve our target product profile of 15 to 20% mean weight loss and thus represent a clear alternative to GLP-1-based therapies,” CEO Adam Steensberg said on a Thursday call with investors.
Zealand plans on initiating a Phase 2b trial this year, and has said it will release more detailed results from the Phase 1b later this year.
While around 80% of participants in the Phase 1b trial were men, a Zealand spokesperson told Endpoints News that they expect the results will be applicable to women.
“It is known that women generally lose more weight than men on these trials,” the spokesperson said.
Common side effects of GLP-1s include gastrointestinal symptoms such as nausea, diarrhea, vomiting and constipation. Zealand said most gastrointestinal events in its Phase 1b trial were mild, except for two moderate nausea and vomiting events experienced by one participant who discontinued treatment. No others reported vomiting, though 16.7% to 33.3% of patients on petrelintide had nausea compared to 16.7% of patients on placebo.
Zealand faces a handful of competitors in the amylin space, including AstraZeneca, which has an early-stage amylin analogue, and Novo Nordisk, which is currently in late-stage testing with its combination amylin analogue and GLP-1 analogue CagriSema.