COPENHAGEN - Zealand Pharma A/S (NASDAQ:ZEAL) has announced positive topline results from a Phase 1b clinical trial of petrelintide, its long-acting amylin analog designed for weight management. The 16-week study showed up to a mean body weight reduction of 8.6% with high dose petrelintide, compared to 1.7% with placebo.
The trial, which aimed to assess the safety, tolerability, and clinical effects of petrelintide, involved approximately 80% male participants with a median age of 49 and a median baseline BMI of 29 kg/m2. They were randomized to receive 16 weekly doses of either the drug or a placebo within three dose cohorts.
According to Dr. David Kendall, Chief Medical Officer of Zealand Pharma, the drug was well tolerated with no serious or severe adverse events reported. Most gastrointestinal side effects were mild, with only two moderate events leading to one participant discontinuing treatment. Notably, no participants discontinued due to adverse events, and no anti-drug antibodies were detected.
The company expects to present more detailed results at a scientific conference later this year and plans to initiate a Phase 2b clinical trial in the second half of 2024. The topline results are based on an interim data cut, with final results to include complete post-treatment follow-up from the third cohort.
Petrelintide has been developed to potentially offer an effective alternative to GLP-1 receptor agonists for weight management, with the goal of providing comparable weight loss but with improved tolerability and a better patient experience.
Zealand Pharma will host a conference call to review the topline results, with participation from CEO Adam Steensberg, CMO David Kendall, and CFO Henriette Wennicke. This announcement is based on a press release statement by Zealand Pharma.
In other recent news, Zealand Pharma has been making substantial progress in the healthcare sector. The biotechnology firm's licensing partner, Boehringer Ingelheim, is set to present positive results from a Phase 2 trial of survodutide for treating metabolic dysfunction-associated steatohepatitis. The data supports survodutide's efficacy in improving liver health.
Zealand Pharma also received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency for its dasiglucagon solution, a treatment for severe hypoglycemia in diabetes patients.
In another development, Zealand Pharma reported topline results from its DREAM trial, which evaluated the effects of its investigational drug dapiglutide in individuals with obesity. The 12-week study showed an average weight loss of up to 4.3% with low doses of the dual GLP-1/GLP-2 receptor agonist.
Furthermore, Zealand Pharma received an Overweight rating from Cantor Fitzgerald and a Buy rating from BTIG, reflecting optimism about the company's potential in the obesity treatment market. Both firms anticipate further growth driven by forthcoming clinical data.
Zealand Pharma is also working on two near-commercial rare disease therapies with little competition, which are expected to be highly successful and potentially reach $1.9 billion in combined peak sales.
InvestingPro Insights
As Zealand Pharma A/S (NASDAQ:ZEAL) advances in its clinical trials for petrelintide, investors are closely monitoring the company's financial health and market performance. With a Market Cap of approximately $5.8 billion, Zealand Pharma stands as a significant player in the biopharmaceutical sector.
Despite challenging market conditions, ZEAL's stock has demonstrated remarkable resilience, with a Year-to-Date Price Total Return of 76.31%, indicating strong investor confidence in the company's growth potential.
InvestingPro data shows an impressive Revenue Growth of 222.76% in the last twelve months as of Q1 2024, underscoring the company's expanding financial base. This substantial increase in revenue is a testament to the company's successful R&D efforts and strategic initiatives. Moreover, the 1 Year Price Total Return of 136.69% reflects a robust market performance, further solidifying the company's position in the eyes of investors.
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The InvestingPro Tips highlight key metrics and trends that are crucial for investors considering Zealand Pharma as part of their portfolio. For instance, the company's Price / Book ratio of 14.44 as of the last twelve months, while on the higher side, might be justified by the company's significant revenue growth and promising pipeline of products like petrelintide. The upcoming Earnings Date on August 15, 2024, will be a pivotal moment for investors to assess the company's progress and future outlook.
Zealand Pharma's focus on developing innovative treatments for weight management, such as petrelintide, aligns with the industry's shift towards addressing obesity and related health issues. As the company prepares for its Phase 2b clinical trial, the financial data and InvestingPro Tips can help investors make informed decisions amidst the ever-evolving biopharmaceutical landscape.
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