Sunday, Sanofi SA’s (NASDAQ:SNY) data from the HERCULES phase 3 study showed that tolebrutinib met the primary endpoint of improvement over placebo in delaying time to onset of confirmed disability progression (CDP) in non-relapsing secondary progressive multiple sclerosis (nrSPMS).
In the HERCULES study, nrSPMS was defined at baseline as having an SPMS diagnosis with an expanded disability status scale (EDSS) score between 3.0 and 6.5, no clinical relapses for the previous 24 months, and documented evidence of disability accumulation in the previous 12 months.
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Preliminary analysis of liver safety was consistent with previous tolebrutinib studies.
The company also released results from the GEMINI 1 and 2 phase 3 studies of tolebrutinib that did not meet the primary endpoint of reducing annualized relapse rate (ARR), compared to teriflunomide, in relapsing forms of multiple sclerosis.
However, analysis of the key secondary endpoint of pooled 6-month confirmed disability worsening (CDW) data showed a considerable delay in time to onset, which supports the CDP data observed in HERCULES.
The PERSEUS phase 3 study in primary progressive multiple sclerosis, evaluating the time to onset of CDP, is currently ongoing, with study results anticipated in 2025.
“Tolebrutinib represents an unprecedented breakthrough as a potential first-in-disease treatment option with clinically meaningful benefit in disability accumulation,” said Houman Ashrafian, Sanofi’s head of research & development.
In 2022, the FDA placed Sanofi’s Phase 3 studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold.
The FDA action was based on a limited number of drug-induced liver injury cases identified with tolebrutinib exposure in Phase 3 studies.
“Despite mixed news, tolebrutinib now appears a largely de-risked perhaps $1 billion-$2 billion opportunity,” Reuters noted, citing Jefferies analysts.
Reuters adds that investors remain cautious due to concerns about potential liver damage and questions surrounding the drug’s effectiveness, which cast uncertainty over its revenue prospects.
Price Action: SNY stock is up 2.84% at $57.86 during the premarket session at last check Tuesday.
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