Understanding cardiac safety early is critical in drug development. In their latest poster, Jazz Pharmaceuticals, explain how they utilised Metrion’s clinically translatable cardiotoxicity assay to do exactly that.
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.
Understanding cardiac safety early is critical in drug development. In their latest poster, Jazz Pharmaceuticals, explain how they utilised Metrion’s clinically translatable cardiotoxicity assay to do exactly that.
Development of a robust hNaV1.9 high-throughput screening assay on the Sophion Qube384 platform. This is complemented by a suite of ion channel selectivity assays and sensory neuron recordings to create a versatile screening cascade to support NaV1.9 drug discovery programmes.