Press Release: Tolebrutinib meets primary endpoint in HERCULES phase 3 study, the first ... - Sanofi
Tolebrutinib met primary endpoint in HERCULES phase 3 study for non-relapsing secondary progressive multiple sclerosis, showing reduction in disability progression. GEMINI 1 and 2 studies in relapsing MS did not meet primary endpoint but showed delay in disability worsening. Results to be discussed with regulatory authorities and presented at ECTRIMS.
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Tolebrutinib met primary endpoint in HERCULES phase 3 study for non-relapsing secondary progressive multiple sclerosis, showing reduction in disability progression. GEMINI 1 and 2 studies in relapsing MS did not meet primary endpoint but showed delay in disability worsening. Results to be discussed with regulatory authorities and presented at ECTRIMS.
Tolebrutinib met its primary endpoint in the HERCULES phase 3 trial, delaying confirmed disability progression in non-relapsing secondary progressive multiple sclerosis (nrSPMS) patients, marking a first in this population. The study evaluated the efficacy and safety of tolebrutinib compared to placebo, addressing a significant unmet medical need.
Tolebrutinib, a Bruton's tyrosine kinase inhibitor, showed efficacy in slowing disability progression in non-relapsing secondary progressive multiple sclerosis (SPMS) in the HERCULES trial, meeting the primary endpoint of delaying 6-month confirmed disability progression. The study also noted increased adverse events, particularly liver enzyme elevations, necessitating stringent monitoring.
Sanofi's phase 3 HERCULES study of tolebrutinib met primary endpoint of reducing disability in non-relapsing secondary progressive multiple sclerosis (nrSPMS). Roche's fenebrutinib showed significant relapse suppression in relapsing MS without disability change. FDA accepted Axsome Therapeutics' resubmitted NDA for AXS-07 for acute migraine treatment.
Tolebrutinib, a BTK inhibitor, significantly slowed disability progression in non-relapsing secondary progressive multiple sclerosis (nrSPMS) patients, delaying 6-month confirmed disability progression by 31% compared to placebo in the phase 3 HERCULES trial. This marks the first significant slowing of disability in this patient population, addressing a significant unmet need.