Sanofi's Tolebrutinib Delays Disability Progression In Patients With Multiple Sclerosis, Data Shows

Friday, Sanofi SA SNY released data from the HERCULES phase 3 study of tolebrutinib for non-relapsing secondary progressive multiple sclerosis (nrSPMS).

The data demonstrated that tolebrutinib delayed the time to onset of 6-month confirmed disability progression (CDP) by 31% compared to placebo (HR 0.69; p=0.0026).

Further analysis of secondary endpoints demonstrated that the number of participants who experienced confirmed disability improvement increased by nearly two-fold, 10% with tolebrutinib compared to 5% with placebo (HR 1.88; nominal p=0.021).

Based on the preliminary analysis of the HERCULES study, there was a slight increase in tolebrutinib-treated patients of some adverse events.

Liver enzyme elevations were observed in 4.1% of participants receiving tolebrutinib compared with 1.6% in the placebo group, a side effect also reported with other BTK inhibitors in MS.

All but one case of liver enzyme elevations were resolved without further medical intervention.

Earlier this month, Sanofi 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 Aubagio (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.

In preliminary analysis of the GEMINI 1 and 2 pooled safety data, adverse events observed between the tolebrutinib and Aubagio arms were generally balanced. Liver enzyme elevations were observed in 5.6% of participants receiving tolebrutinib compared with 6.3% of participants receiving Aubagio.

Study results will form the basis for future discussions with global regulatory authorities, with submissions starting in H2 2024.

The PERSEUS phase 3 study in primary progressive MS is ongoing, with study results anticipated in H2 2025.

Price Action: SNY stock is down 0.53% at $57.95 during the premarket session at last check Friday.

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