(News Bulletin 247) – The pharmaceutical group’s action took off this Tuesday after the pharmaceutical group and its partner Teva announced satisfactory results from a phase 2b clinical trial for duvakitug, a potential treatment against ulcerative colitis and the disease of Crohn’s.
Sanofi shares experienced a sudden boost this Tuesday. While it was in balance, the stock took off almost suddenly, gaining more than 2%, shortly after 1:30 p.m. At the end of the session, the pharmaceutical group’s shares rose more than 3.1%, marking the largest increase in the CAC 40.
This sudden increase occurred in the wake of an announcement, at 1:30 p.m., with its Israeli partner Teva, whose ADR (a security allowing American investors to speculate on foreign groups) takes 20.5% on Wall Street .
The two groups have communicated positive results for a phase 2b trial (an intermediate stage in clinical trials, before phase 3, which marks the last step before potential marketing of the drug) for duvakitug.
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Criteria met
This molecule is a monoclonal antibody that has the potential to treat inflammatory bowel disease (IBD). Specifically, the clinical trial, called “RELIEVE UCCD” evaluated duvakitug to treat ulcerative colitis, an inflammation of the lining of the large intestine, and Crohn’s disease, a chronic inflammatory disease of the digestive tract. The symptoms of these diseases can be very debilitating (diarrhea, rectal bleeding, fatigue) or even result in fibrosis (tissue destruction) and hospitalization. There is currently no cure for these diseases.
The phase 2b clinical trial (which evaluates the effectiveness of the drug) met its primary endpoints. For ulcerative colitis, 36.2% and 47.8% of patients treated with low dose and high dose duvakitug, respectively, experienced clinical remission, compared to 20.45% of patients treated with placebo.
In Crohn’s disease patients, 26.1% of those who received a low dose of duvakitug had an endoscopic response (a response of the mucosa to treatment) compared to 47.8% of those who received a low dose of duvakitug. high dose and 13% for those treated with placebo.
A future blockbuster
“Duvakitug was generally well tolerated in both ulcerative colitis and Crohn’s disease, and no safety signals were identified,” Sanofi said. These results “show that duvakitug could represent a new step in the treatment of ulcerative colitis and Crohn’s disease,” said Houman Ashrafan, Sanofi vice president in charge of R&D.
“If the magnitude of its effect is verified in the phase III program, we believe that we will then have a differentiated drug for IBD patients who urgently need to offer new treatment options,” he said. he added.
These clinical data “are very good and Sanofi can deliver a future blockbuster,” underlines an analyst.
Duvakitug is one of the 12 drug candidates in its clinical portfolio that Sanofi had identified as having strong commercial potential, during its R&D day in December 2023. This antibody can, like eight other molecules, generate sales which would reach a peak located between 2 billion and 5 billion euros. Sanofi, however, expects to submit this drug candidate to health authorities for approval after 2027.
This drug candidate targets IBD, a market estimated by UBS to be worth $30 billion in 2028. The bank, in its forecast, included a risk-adjusted revenue target for duvakitug at an annual peak of $1.5 billion .
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