Inhibition of hERG by siRNA Takes More Than 8 hrs to Manifest: Implications for Designing hERG Assays

Poster Description

Nonclinical safety pharmacology studies for siRNA follow a hybrid of the small molecule (SM) guidance and biologics guidance. The Oligonucleotide Safety Working Group (OSWG) has published a series of recommendation papers for oligonucleotides, including recommendations for safety assessment, because development of oligonucleotide-based therapeutics is not addressed by regulations. This is especially true regarding the hERG assay, which is a core assay in ICH S7B for SM. While OSWG states that a hERG study is not necessary for IND submission, all approved siRNAs have submitted hERG data which are necessary for requesting a TQT waiver.

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