Sanofi scraps PhI­II tri­al for Prin­cip­ia drug af­ter re­view­ing com­pe­ti­tion

Months af­ter the FDA placed Phase III tri­als of Sanofi’s BTK in­hibitor on hold, the com­pa­ny is wind­ing down one of the stud­ies.

Sanofi re­port­ed in its Q4 earn­ings that the UR­SA study “was dis­con­tin­ued af­ter care­ful eval­u­a­tion of the emerg­ing com­pet­i­tive treat­ment land­scape in” myas­the­nia gravis, a rare dis­ease that caus­es mus­cle weak­ness.

The Phase III, place­bo-con­trolled tri­al was test­ing tole­bru­ti­nib in pa­tients with the mod­er­ate-to-se­vere form of the dis­ease. It start­ed in late 2021, ac­cord­ing to records on clin­i­cal­tri­als.gov, and was orig­i­nal­ly de­signed to re­cruit 154 par­tic­i­pants who were re­ceiv­ing the stan­dard of care.

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