FDA hands Ar­bu­tus clin­i­cal hold on IND for he­pati­tis PD-L1

The FDA placed a clin­i­cal hold on Ar­bu­tus Bio­phar­ma’s ex­per­i­men­tal PD-L1 that is de­signed to treat pa­tients with chron­ic he­pati­tis B virus.

The biotech an­nounced the reg­u­la­to­ry ac­tion on Tues­day morn­ing, say­ing that it re­ceived ver­bal no­tice from the FDA about the hold on its IND ap­pli­ca­tion for AB-101.

Ar­bu­tus, which did not pro­vide a rea­son for the hold, said it ex­pects to get the of­fi­cial clin­i­cal hold let­ter with­in 30 days. The com­pa­ny said that it no longer plans to re­port ini­tial da­ta from a sin­gle-as­cend­ing dose por­tion of a planned Phase I tri­al in the first half of this year due to the FDA’s ac­tion.

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