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Liver injuries trigger clinical hold on Sanofi’s BTK drug

Published on 04/07/22 at 09:37am

The FDA has placed a partial clinical hold on Sanofi’s Phase III BTK inhibitor trial, following reports of drug-induced liver damage in certain subjects. The hold on dosing applies to subjects in the trials who have received the drug for less than 60 days.

Sanofi said that most of the cases involved patients who were already at elevated risk of liver side effects due to concomitant medical conditions, and elevated enzyme levels used as biomarkers for liver injury fell after treatment with tolebrutinib was halted.

The company also said that it had been aware of the issue, and modified the protocol of the study last month to increase the frequency of liver toxicity testing and exclude recruitment of people with risk factors for liver disease.

The BTK inhibitor, tolebrutinib (SAR442168), is one of three clinical-stage candidates that Sanofi acquired with the Principa takeover, and is the second to suffer a setback after rilzabrutinib failed a trial involving patients with rare autoimmune skin disorder pemphigus last September. Rilzabrutinib remains in development despite the miss, but the tolebrutinib development is likely more serious as the drug is in competition in MS with other BTK inhibitors from Merck KGaA, Roche, and Biogen.

Outside the US, the studies will continue as planned with the tighter safety monitoring.

All BTK inhibitors are designed to be able to cross the blood brain barrier and enter the central nervous system, softening the autoimmune response that leads to neuronal damage in MS.

Lina Adams

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