Regulus Therapeutics received a $10 million equity investment from sanofi-aventis in connection with their alliance, which began on June 21 and is initially focused on fibrosis. Sanofi-aventis thus joins Alnylam Pharmaceuticals and Isis Pharmaceuticals as an investor in Regulus.
The collaboration between Regulus and sanofi-aventis is valued at over $750 million. It covers the discovery, development, and commercialization of miRNA therapeutics for four targets including Regulus’ leading fibrosis program targeting miRNA-21.
Regulus says that its preclinical studies have shown that anti-miR-21 can reverse fibrosis and significantly improve cardiac function in mice with failing hearts. It has also observed similar therapeutic results in other models of fibrosis. The anti-miR-21 program is currently at the compound-optimization phase.
The investment of $10 million represents less than 10% ownership of preferred outstanding shares. The remaining preferred outstanding shares are owned equally by Alnylam and Isis. “With the addition of $10 million from the sanofi-aventis equity investment, Regulus has to date raised $40 million from equity financings and over $58 million from strategic pharmaceutical alliances,” notes Garry E. Menzel, Ph.D., evp of corporate development and finance at Regulus.
In April 2008, Regulus and GlaxoSmithKline (GSK) inked a deal in immuno-inflammatory diseases. Valued at nearly $600 million, the alliance provides GSK with an option to exclusively license candidates directed at four miRNA targets.
This February Regulus and GSK initiated a new $150 million partnership to develop and commercialize therapeutics targeting miRNA-122 for HCV. GSK gained rights to Regulus’ miR-122 antagonist, which may also be expanded to other diseases. At the time the agreement was made, Regulus expected to file an IND application in 2011.
Regulus scientists and collaborators performed studies to show that anti-miR-122 reduces cholesterol levels in blood and reverses hepatic steatosis in obese mice. More recent preclinical investigations demonstrate that miR-122 is essential for replication of HCV. Together, these findings suggest that anti-miR-122 may both reduce HCV infection and improve HCV-associated pathologies like fatty liver.