(Bloomberg) -- Shares of Novo Nordisk A/S fell after the Danish drugmaker reported mixed safety data on one of its next-generation weight-loss drugs.
A mid-stage trial showed that monlunabant helped generate statistically significant weight loss compared with placebo, but with limited additional losses seen at higher doses. The trial of 243 people had no serious adverse events, but mild to moderate neuropsychiatric side effects, primarily anxiety, irritability, and sleep disturbances, were more frequent and dose dependent with the drug than with placebo.
The results cast a pall over Novo’s efforts to resurrect a once-maligned class of drugs. The company acquired monlunabant last year in its purchase of Canadian biotech Inversago Pharma, a deal that would have been worth as much as $1.1 billion if development goals were hit.
Novo’s shares fell as much as 5.3% on the news, the most since Aug. 7. Shares of Skye Bioscience Inc. and Corbus Pharmaceuticals Holdings Inc., US-listed biotech companies that are developing drugs that use a similar approach to monlunabant, also fell more than 45% and 65% respectively after US markets opened.
The results “raise questions over the commercial viability” of the class of drugs that includes monlunabant, said Bloomberg Intelligence analyst Michael Shah. The side-effect reports are concerning and the weight loss shown in the trial lags behind that shown by rival Eli Lilly & Co.’s pill orforglipron, Shah said.
Monlunabant is an experimental compound that targets type 1 cannabinoid receptors, or CB1 receptors. The drug uses a similar approach to rimonabant, an obesity drug that European regulators pulled off the market two decades ago due to concerns it was tied to suicidal ideation.
At a meeting with investors in March, Novo executives argued it would be possible to selectively target beneficial cannabinoid receptors without the same psychiatric side effects. But today’s results show “further work is needed to determine the optimal dosing to balance safety and efficacy,” said Martin Holst Lange, Novo’s executive vice president and head of development.
The drugmaker said it will initiate a larger trial to further investigate dosing and safety of the drug.
--With assistance from Madison Muller.
(Updates to include Inversago deal and analyst comment. An earlier version corrected spelling of Corbus Pharmaceuticals.)
©2024 Bloomberg L.P.
