FDA Approves Quark IND for DGFi, an siRNA therapeutic based on Silence Therapeutics’ Proprietary Chemistry

Silence Therapeutics plc announces that the U.S. Food and Drug Administration (FDA) has approved a Quark Pharmaceuticals Inc (Quark) Investigational New Drug application (IND) for an siRNA therapeutic product based on Silence’s proprietary chemistry.

The product, DGFi, was discovered and is being developed by Quark for use in kidney transplantation. Rights to the AtuRNAi structure of DGFi were licensed to Quark by Silence Therapeutics.

DGFi is being investigated for the prevention and treatment of Delayed Graft Function (DGF) associated with renal transplantation.  DGF is a syndrome caused by ischemia and reperfusion injury, which frequently occurs in kidneys once they are removed from a donor and transplanted into the patient.

In patients with DGF, the transplanted kidney does not function properly and requires intervention by dialysis. DGFi is designed to temporarily inhibit the activity of the p53 gene, which is associated with apoptosis, also known as programmed cell death, and is believed to be critical in the ischemia and reperfusion injury process.

DGFi uses the same active AtuRNAi molecule as AKIi-5, which Quark is developing for treatment of Acute Kidney Injury.

Jeff Vick, Chief Executive Officer of Silence Therapeutics, said “We are very excited by this news, as it is the third IND approved for a product based upon our proprietary AtuRNAi chemistry and confirms our leading position in this revolutionary field of technology.”