COPENHAGEN - Zealand Pharma A/S (NASDAQ:ZEAL), a biotechnology firm, today announced positive topline results from a 13-week Phase 1b trial of dapiglutide, a dual GLP-1/GLP-2 receptor agonist designed for weight management. The trial demonstrated up to an 8.3% reduction in body weight compared to placebo after 13 weekly doses.
The study involved 54 participants, primarily male, with a median age of 46 and a median baseline BMI of 30.0 kg/m^2. They received dapiglutide or placebo within three dose cohorts. Results showed a mean weight loss of up to 6.2% for those treated with dapiglutide, while the placebo group saw a 2.1% mean weight gain.
According to Dr. David Kendall, Chief Medical Officer of Zealand Pharma, the data support dapiglutide's unique profile and its potential positive effect on inflammation. The trial, which did not include lifestyle modifications, also found that dapiglutide was safe and well-tolerated, with gastrointestinal side effects consistent with other incretin-based therapies.
No severe treatment-emergent adverse events were reported, and only two participants discontinued due to moderate vomiting. A low number of participants experienced mild injection site reactions, and 14.3% developed anti-drug antibodies.
The ongoing Part 2 of the trial is examining higher doses of up to 26 mg over 28 weeks, with results expected in the first half of 2025. The company also plans to initiate a comprehensive Phase 2b trial in the first half of 2025 to explore dapiglutide's use in individuals with overweight and obesity, as well as in select obesity-related comorbidities.
This news is based on a press release statement from Zealand Pharma. The company's focus on peptide-based medicines has led to two market products and several in late-stage development. The trial's findings are expected to be presented at a future scientific congress, with further details on both parts of the Phase 1b trial.
In other recent news, Zealand Pharma reported significant developments in its operations. The company has expanded its equity offering to $1 billion, reflecting strong investor demand. This move is intended to support their research and development activities, as well as the commercialization efforts for their marketed products. Zealand Pharma's second-quarter results highlighted progress in their product pipeline, with Goldman Sachs (NYSE:GS) maintaining a Conviction Buy rating and raising the price target for the company.
In the realm of drug development, Zealand Pharma's obesity treatment petrelintide showed promising results, with an anticipated initiation of Phase 2b trials in the second half of 2024. The company's investigational drug, dapiglutide, demonstrated an average weight loss of up to 4.3% in a 12-week study. Furthermore, the drug candidate survodutide showed efficacy in improving liver health in a Phase 2 trial, earning Fast Track Designation from the U.S. Food and Drug Administration for MASH and fibrosis treatment.
Analysts have expressed optimism about Zealand Pharma's potential in the obesity treatment market, with the company receiving an Overweight rating from Cantor Fitzgerald and a Buy rating from BTIG. These recent developments highlight the company's ongoing efforts in advancing their drug pipeline and securing funding for their operations.
InvestingPro Insights
As Zealand Pharma (NASDAQ:ZEAL) makes headlines with the promising results of its dapiglutide trial, investors may be weighing the company's financial metrics to understand its market position. Zealand Pharma's market capitalization stands at $8.99 billion, reflecting investor confidence in the company's growth trajectory, especially in light of recent clinical advancements.
The company's revenue has seen a staggering growth of over 301% in the last twelve months as of Q2 2024, signaling a robust expansion in its financial performance. This growth is mirrored in the quarterly revenue increase of about 228%, underscoring the company's potential to capitalize on its clinical pipeline. Despite these impressive growth figures, it's essential to note that Zealand Pharma is currently operating at a loss, with a negative gross profit margin of -94.16% and an operating income margin of -195.86% in the same period.
Investors should also consider that the company's P/E ratio is negative at -72.72, which may suggest expectations of future earnings or that the stock is currently overvalued. Moreover, the InvestingPro Fair Value estimate is $73.79, which stands below the previous close price of $122.51, potentially indicating that the stock might be overpriced according to certain analytical models.
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