Reg­u­lus craters af­ter FDA slaps a hold on hep C RNA drug fol­low­ing 2nd case of jaun­dice

Just days af­ter set­ting up a $30 mil­lion line of cred­it to ramp up work on its he­pati­tis C ther­a­py RG-101, Reg­u­lus Ther­a­peu­tics has been forced to slam the brakes on its clin­i­cal pro­gram af­ter the FDA slapped a clin­i­cal hold on the drug af­ter re­searchers re­port­ed a sec­ond case of jaun­dice among pa­tients tak­ing it.

“The SAE oc­curred in a HCV pa­tient with end-stage re­nal dis­ease on dial­y­sis en­rolled in its on-go­ing Phase I US study 117 days af­ter re­ceiv­ing a sin­gle dose of RG-101,” the com­pa­ny said in a state­ment. Reg­u­lus claimed that its de­vel­op­ment time­line won’t be im­me­di­ate­ly af­fect­ed as all pa­tients for three on­go­ing tri­als have been re­cruit­ed and dosed.

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