As a rival to Novo Nordisk and Eli Lilly's weight loss pills comes. The Phase II trial of survodutide, a drug owned by Danish pharmaceutical company ZealandPharma, showed that 83% of adult subjects showed positive effects on the drug in treating metabolic dysfunction-associated steatohepatitis (MASH). It hopes to launch it as early as 2027. Analysts said the trial results showed a "clear victory" for the drug.
The booming weight-loss drug market has made a lot of money for many pharmaceutical companies, and Danish pharmaceutical company ZealandPharma is not far behind. The company announced a trial result on Monday showing that one of its liver disease treatment drugs is effective, spurring the company's stock price to soar 36% on Monday.
ZealandPharma and its research and development partner Boehringer Ingelheim said in an announcement on Monday that a phase II trial of the company's survodutide drug showed that 83% of adult subjects showed a positive effect on the drug in treating metabolic dysfunction-associated steatohepatitis (MASH), compared with only 18.2% of the comparable group who received placebo.
It is understood that the drug survodutide suppresses appetite by mimicking the intestinal hormone GLP-1 (glucagon-like peptide-1), just like other injectable weight loss drugs, but the drug also mimics another intestinal hormone called glucagon.
Trials have shown that the drug "shows efficacy" in obese people, and there are currently five Phase III clinical trials in overweight or obese people. The drug has been designated as a fast track development drug by the U.S. Food and Drug Administration (FDA). The trial results show that the drug is safe even at the highest doses.
Previously, there have been fires involving various weight-loss drugs that have caused the stock prices of manufacturers to soar. Novo Nordisk, also from Denmark, has become the company with the highest market value in Europe because of its development of weight-loss drugs Ozempic and Wegovy. Analysts have also begun to pay attention to the possible effectiveness of this drug in the treatment of obesity, and ZealandPharma's share price surged 36.45% in London on Monday. Several other companies, including Eli Lilly, Roche and AstraZeneca, are also looking to compete in the space.
Carinne Brouillon, head of Boehringer Ingelheim's human medicines division, said she hopes the drug will be launched in 2027 or 2028, depending on whether phase three trial results are favorable. She added that the diagnostics industry is looking into blood tests and non-invasive imaging techniques to better identify patients with early-stage MASH hepatitis. The company said details of the trial will be presented at an undisclosed medical conference in the first half of this year.
Analysts said in a report released on Monday that the results of the ZealandPharma trial showed a "clear victory" for survodutide. "Preliminary results show that various doses of survodutide used in the trial were effective in treating MASH hepatitis, and treatment with survodutide showed no unexpected safety or tolerability issues, including at the higher dose of 6.0 mg."
He added: "Importantly, the [Phase II] MASH trial also tells us that the 6mg dose is safe, which is also the highest dose used in the ongoing [Phase III] obesity trial."
Some analysts have assessed that ZealandPharma’s status as a key player in the next wave of obesity treatment has been underestimated. Currently, German pharmaceutical company Boehringer Ingelheim is funding and conducting clinical development of survodutide. Analysts noted that Boehringer Ingelheim's announcement that the drug will advance the treatment of liver disease and related conditions "as quickly as possible" is important.
MASH hepatitis, formerly known as nonalcoholic steatohepatitis, is caused by diet-related fat accumulation in the liver, causing inflammation that may subsequently lead to cirrhosis. Data show that there are an estimated 115 million people suffering from MASH hepatitis worldwide, and some patients require organ transplants.
Although no treatment is currently available, several other drug manufacturers have considered treating the disease as an additional use for new obesity drugs. Weight loss drug pioneer Novo Nordisk is conducting a Phase 3 trial of semaglutide, the active ingredient in its Wegovy weight loss injection, against MASH hepatitis.
At the same time, Eli Lilly's weight loss drug Mounjaro (also known as Zepbound) is also testing the drug's active ingredient in a phase II trial for MASH hepatitis. The drug has a dual mechanism of action. It is based on two hormones, GLP-1 and GIP (gastric inhibitory peptide), which can not only promote the release of insulin to lower blood sugar levels, but also affect appetite and energy expenditure, thereby helping weight management.