Almost three years after an initial collaboration was announced, AstraZeneca (AZN) has selected the first clinical candidate from a discovery program with Regulus Therapeutics (RGLS). RGLS jumped 15% with the news.
Regulus announced on Wednesday evening that AstraZeneca has selected as a clinical candidate RG-125 (now called AZD4076), a GalNAc-conjugated anti-miR targeting microRNA-103/107 (miR-103/107) for the treatment of Non Alcoholic Steatohepatitis (NASH) in patients with type 2 diabetes/pre-diabetes. Under the terms of the deal, AstraZeneca will pay RGLS $2.5 million and will assume development of the program once an Investigational New Drug application has been accepted by the FDA.
Regulus and AstraZeneca will present preclinical data from the program at a scientific meeting and initiate a Phase I study in humans by the end of 2015.
The AZN-RGLS alliance was inked in August of 2012, with AstraZeneca putting $25 million into RGLS’ IPO (October of that year) and another $3 million upfront. The program is for the discovery and development of microRNA therapeutics for cardiovascular diseases, metabolic diseases and oncology settings. Wednesday’s miR-103/107 target is the first clinical candidate under the alliance.
