On Thursday, Danish biotechnology company Zealand Pharma announced positive top-line results from its phase Ib trial of the long-acting amylin analog petrelinotide.
Due to the timing of the announcement after European market hours, Zealand Pharma’s stock surged more than 9% in after-hours trading on Thursday in the US.
Zealand Pharma has been a standout in the weight-loss drug sector over the past two years, notably outperforming its Danish counterpart, Novo Nordisk, in terms of stock gains. Listed on the Copenhagen Stock Exchange, Zealand Pharma saw an 85% increase last year and has already risen by 73% this year, compared to Novo Nordisk’s annual gains of 40-50%.
Petrelinotide, Zealand Pharma’s new drug, works similarly to GLP-1 receptor agonists familiar to investors, such as semaglutide and liraglutide, but is a distinct medication. Amylin is a peptide hormone secreted by pancreatic β-cells, while GLP-1 is secreted by intestinal L-cells. Both can suppress appetite, slow gastric emptying, and inhibit glucagon secretion.
Zealand Pharma emphasized in its announcement that recent trial results suggest petrelinotide could be a viable alternative for weight management compared to GLP-1 receptor agonists. Clinical data and studies indicate that petrelinotide has the potential to offer similar weight loss effects with better tolerability, thus providing a potentially better experience for weight loss while preserving lean muscle mass.
In the phase Ib trial disclosed by Zealand Pharma, involving 48 participants (80% male) with a median age of 49 and a median BMI of 29, subjects received weekly injections of petrelinotide over a 16-week period. Results showed that participants in the high-dose group achieved an average weight reduction of 8.6% from baseline, compared to only 1.7% in the placebo group.
No serious adverse events occurred during the entire trial, with only one participant reporting two moderate events (nausea and vomiting) after the third injection. Apart from this participant, no vomiting was reported by any other participants who completed the entire treatment process. The incidence of nausea across all active groups ranged from 16.7% to 33.3%, compared to 16.7% in the placebo group.
Dr. David Kendall, Chief Medical Officer of Zealand Pharma, expressed confidence that these trial results support the belief that petrelinotide is well-tolerated and could serve as a substitute for glucagon-like peptide drugs in the management of overweight and obesity.
Looking ahead, Dr. Kendall noted that these data pave the way for rapid progression to phase IIb trials for petrelinotide, with expectations to initiate clinical trials in overweight and obese patients later in 2024.
Despite these promising developments, Zealand Pharma will continue to face competition, particularly from Novo Nordisk’s compound CagriSema, a combination of long-acting amylin analog Cagrilintide and semaglutide, currently undergoing phase III clinical trials in multiple countries, including China. Preliminary results suggest that the combination therapy is more effective for weight loss than either drug alone.
As Zealand Pharma advances its efforts in the field of amylin-based weight-loss medications, it will need to navigate and differentiate itself in a competitive landscape, particularly against its Danish counterpart.
