Regulus Therapeutics acknowledged today that clinical development of its nonalcoholic steatohepatitis (NASH) candidate AZD4076 (RG-125) is being halted by AstraZeneca—one of three Regulus pipeline candidates whose clinical programs are being scuttled.
Regulus said development is also being halted on its lead RNA interference (RNAi) candidate RG-101, or anti-microRNA-122 (anti-miR-122), for hepatitis C virus (HCV), as well as its RGLS5040 (anti-miR-27) for cholestatic disease—in addition to AZD4076 (RG-125), which is indicated for NASH in type 2 diabetes/pre-diabetes.
AZD4076 (RG-125) is a N-acetylgalactosamine (GalNAc)-conjugated anti-miR-103/107 oligonucleotide that AstraZeneca selected for development in 2015 under an up-to-$526 million strategic alliance announced by the companies three years earlier to discover, develop, and commercialize compounds targeting three miRNA targets in cardiovascular diseases, metabolic diseases, and oncology.
Under that alliance, AstraZeneca paid $28 million to Regulus, consisting of a $25 million equity investment (made concurrent with Regulus’ IPO in 2012) and a $3 million up-front payment. Regulus earned a $2.5 million milestone payment in April 2015 for the clinical candidate selection and was eligible to receive up to $495.5 million in future milestone payments.