(BFM Bourse) – Tolebrutinib has successfully completed a phase III study in the treatment of multiple sclerosis but did not reach its criterion in another phase III study. This is nevertheless enough to carry its title.
Sanofi’s recent history has been marked by some setbacks in terms of R&D. For example, in 2022, the company abandoned the development of amcenestrant, a potential oral treatment for certain breast cancers, following disappointing clinical trials.
The group has since decided to work twice as hard to boost its R&D and launch new drugs likely to reduce its dependence on Dupixent, its blockbuster.
Last December, Sanofi presented to the market a portfolio of twelve molecules currently undergoing clinical studies and whose potential revenues could amount to between 2 billion and more than 5 billion euros per year at cruising speed for each molecule.
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Mixed results
Among these twelve promising molecules is tolebrutinib, a potential treatment for various forms of multiple sclerosis, which must be submitted for approval to the regulatory authorities before the end of the year.
The market was awaiting the results of two phase III clinical trials (the last phase before potential marketing authorization) this September, “Hercules” and “Gemini”, evaluating tolebrutinib in several forms of multiple sclerosis.
Let us recall that multiple sclerosis is an extremely disabling disease that affects the nervous system. This disease often develops in flare-ups (the so-called “remitting” form) and causes motor, visual, cognitive and urinary disorders. It often affects young adults, around the age of 30, and particularly affects women. Around 123,000 people are affected by it in France, 72% of whom are women.
Sanofi announced Monday that tolebrutinib met its primary endpoint in the Hercules study, evaluating the treatment in people with non-active secondary progressive multiple sclerosis. The endpoint was the prolongation of time to confirmed disability progression compared to placebo.
The molecule did not, however, reach its primary endpoint in the second study, Gemini (or more precisely two studies, Gemini 1 and 2). This trial evaluated tolebrutinib to treat people with relapsing-remitting forms of multiple sclerosis (RRMS). The primary endpoint corresponded to the reduction in the annualized relapse rate, compared to teriflunomide, another molecule already marketed by Sanofi under the name Aubagio.
Well on its way to becoming the “standard of care”
A third phase III study, “Perseus,” is currently evaluating tolebrutinib to slow disease progression in patients with primary progressive multiple sclerosis. Results are expected in 2025.
Sanofi will present the results of the “Hercules” and “Gemini 1 and 2” studies at the next congress of the European Committee for Treatment and Research in Multiple Sclerosis to be held on September 20, 2024 in Copenhagen, Denmark.
If Invest Securities ultimately believes that the results presented on Monday constitute a “very contrasting success”, Sanofi shares take off.
The title rose 2.1% around 11:15 a.m., marking the biggest increase in an anemic CAC 40 (-0.3%).
“Expectations for both indications for tolebrutinib were low, so the fact that one of the two studies was successful is well received. This means that the drug candidate has a good chance of being adopted for at least one of these two indications,” explains a financial intermediary. “Moreover, these are the first robust phase III results for Sanofi in some time, which plays on market sentiment,” he adds.
In a note, Stifel points out that “Hercules”, the successful trial carried out by Sanofi, was the study whose success was the most important in the eyes of the market.
“First, because Merck failed in December 2023 with both ‘Evolution’ trials and the Gemini studies were very similar in design and construction,” the bank explains.
Then because the Hercules trial “was also different and unique. The population is the one that needs treatment the most because the existing options are not working well,” Stifel continues.
“With the success of Hercules, tolebrutinib is poised to become the SoC (the “standard of care”, i.e. the treatment deemed most appropriate by medical experts) for non-active secondary progressive multiple sclerosis where there is a very high unmet medical need,” concludes Stifel.
Before the results of these studies, the research office was counting on $1.9 billion in sales for tolebrutinib, more than 80% of which would be for the indication linked to the Hercules clinical trial.
Julien Marion – ©2024 BFM Bourse
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