Sanofi: mixed Phase III data in MS
(CercleFinance.com) - Sanofi reports positive Phase III results for tolebrutinib in non-active secondary-progressive multiple sclerosis (SPMS), but more mixed results in relapsing-remitting MS (RRMS).
In the HERCULES study, tolebrutinib met the primary endpoint and increased time to confirmed disability progression compared to placebo in non-active SPMS.
However, the primary endpoint of the GEMINI 1 and 2 RRMS studies, namely a reduction in the annualised relapse rate, failed to reach statistical significance compared with Aubagio.
Analysis of six months of pooled data for the primary secondary endpoints confirmed a significant increase in time to disability progression, Sanofi says about GEMINI 1 and 2.
The results of these Phase III studies will be presented at the ECTRIMS congress in Copenhagen on 20 September. They will form the basis for future discussions with regulatory authorities.
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In the HERCULES study, tolebrutinib met the primary endpoint and increased time to confirmed disability progression compared to placebo in non-active SPMS.
However, the primary endpoint of the GEMINI 1 and 2 RRMS studies, namely a reduction in the annualised relapse rate, failed to reach statistical significance compared with Aubagio.
Analysis of six months of pooled data for the primary secondary endpoints confirmed a significant increase in time to disability progression, Sanofi says about GEMINI 1 and 2.
The results of these Phase III studies will be presented at the ECTRIMS congress in Copenhagen on 20 September. They will form the basis for future discussions with regulatory authorities.
Copyright (c) 2024 CercleFinance.com. All rights reserved.