消息面上，诺和诺德在官网发布了药物“monlunabant”2a期临床试验的主要结果。整体来看，Compared with placebo, monlunabant has a statistically significant weight loss. However, the additional weight loss effect is limited in the higher dose group. According to the research results, Novo Nordisk is expected to initiate a larger-scale phase 2b trial for obesity in 2025.
On Friday (September 20th), the stock price of Danish pharmaceutical giant Novo Nordisk fell nearly 6% in early trading of the US stock market, with a lowest intraday price of $126.13 per share, the lowest level since August 9th.
Daily chart of Novo Nordisk stock price
On the news front, Novo Nordisk published the main results of the phase 2a clinical trial of the drug 'monlunabant' on its official website. Overall, the drug has a statistically significant weight loss compared to placebo. However, the additional weight loss effect is limited in the higher dose group.
It is known that monlunabant is a small molecule oral CB1 receptor inverse agonist developed by Inversago Pharmaceuticals Inc., used for the treatment of metabolic syndrome, obesity, and diabetic nephropathy. Last August, Novo Nordisk acquired the company and obtained the pipeline for monlunabant.
Source: Novo Nordisk official website
In the previous phase 1b study, monlunabant reduced the average weight of the participants by 3.5kg (3.3%) within 28 days, with significant decreases in waist circumference and BMI. The drug was well-tolerated and no serious adverse events were reported.
In the latest phase 2a trial data released today, 243 patients with obesity and metabolic syndrome, with an average weight of 110.1kg, were randomly divided into four groups. Over a period of 16 weeks, three groups received daily doses of 10mg, 20mg, and 50mg of monlunabant respectively, while the fourth group received a placebo.
The results showed that all doses of monlunabant achieved statistically significant weight loss compared to the placebo group. The 10mg group experienced a weight loss of 7.1kg, while the placebo group lost 0.7kg. However, the additional weight loss effect of the higher dosage group was limited compared to the 10mg group.
There were no serious adverse events reported in the trial. The most common adverse events were gastrointestinal. Compared to the placebo group, the monlunabant group reported mild to moderate neuropsychiatric side effects, mainly anxiety, irritability, and sleep disorders.
Martin Holst Lange, Executive Vice President of Global Development at Novo Nordisk, wrote that the phase 2a study results indicate the potential of monlunabant in weight reduction. Further research is needed to determine the optimal dosage to balance its safety and efficacy.
Lange added that obesity is a complex disease with significant unmet needs. As an oral small molecule with a novel mechanism of action, monlunabant is one of the promising new projects in their research pipeline for treating obesity.
According to the study results, Novo Nordisk plans to initiate a larger phase 2b trial for obesity in 2025 to further investigate the long-term administration and safety of monlunabant in a global population.
It is worth mentioning that a weight-loss drug called "rimonabant" was approved in Europe in 2006, which had a similar mechanism to monlunabant. However, rimonabant was withdrawn globally in 2008 due to severe neuropsychiatric side effects.
In addition to Novo Nordisk, Skye Bioscience, Inc. and Corbus Pharmaceuticals Holdings, Inc. in the United States are also developing drugs with similar mechanisms. Due to the impact of monlunabant, the stock prices of both companies fell by more than 44% and 59% respectively.