Novo Nordisk leaps on new obesity drug data
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Shares in Novo Nordisk were up nearly 12% today – hiking its valuation to more than $280 billion – after it reported new clinical data with one of its obesity drug candidates.
The new results with a once-weekly subcutaneous injection of amycretin – which is also being developed in a daily oral formulation – show that the combined GLP-1 and amylin agonist achieved up to 22% weight loss at 36 weeks.
The phase 1b/2a trial in 125 people with obesity or overweight combined single ascending dose, multiple ascending dose, and dose-response assessments and looked at three different doses of amycretin; namely, 1.25mg, 5mg, and 20mg.
It also showed that the drug was well tolerated, with side effects mainly gastrointestinal complaints like nausea and diarrhoea that are typical of this type of incretin-based therapy, according to the company, which said most were mild to moderate in severity.
The results are a boost to Novo Nordisk after another weight-loss therapy, CagriSema (cagrilintide and semaglutide), delivered lower-than-hoped-for weight loss of 20.4% at 68 weeks in a phase 3 obesity trial reported in December.
Novo Nordisk is currently leading the market for incretin therapies with semaglutide-based products Ozempic for type 2 diabetes and Wegovy for obesity, but is coming under competitive pressure from rival therapies from Eli Lilly based on dual GIP/GLP-1 agonist tirzepatide.
Lilly's obesity therapy recently outperformed Wegovy in a head-to-head weight loss study, while CagriSema's top-line efficacy was in the same ballpark as Zepbound in the phase 3 readout.
The new study showed that subcutaneous amycretin achieved a 9.7% reduction from an average starting body weight of just under 93kg at 20 weeks, rising to 16.2% with 5mg at 28 weeks, and 22% at 20mg at the 28-week timepoint.
For comparison, people treated with placebo experienced an estimated 1.9%, 2.3%, and 2.0% body weight gain, respectively.
Novo Nordisk's head of development said he was "very encouraged" by the new data, saying it supports "the weight-lowering potential of this novel unimolecular GLP-1 and amylin receptor agonist […] that we have previously seen with the oral formulation."
Last year, oral amycretin was shown in a phase 1 trial to achieve approximately 10% weight loss at a daily dose of 50mg at 12 weeks, with patients taking 100mg per day seeing a 13% reduction.
Novo Nordisk said it is now planning to advance both subcutaneous and oral formulations of amycretin into additional clinical trials. The new data follows another study that showed the effectiveness of Wegovy could be stepped up by raising the weekly dose of the drug.
The size of the company's share price increase today could also reflect a bounceback from a fall-off in the stock's value last week, after the revelation that Wegovy, Ozempic, and another semaglutide-based diabetes therapy called Rybelsus have been included on the list of the next 15 drugs to be subject to Medicare pricing negotiations.
Image by Peggy und Marco Lachmann-Anke from Pixabay