GNI Ltd and EpiCept Corporation have announced that they have reached agreement to develop a new therapeutic drug, EP1013, in Asia, Australia, and New Zealand, for late-stage viral infection-induced hepatitis. EpiCept will retain the rights in the rest of the world. GNI’s wholly owned subsidiary, Shanghai Genomics, will start preparation for pre-IND and clinical development in China immediately.
In return for granting a license to GNI to develop EP1013, EpiCept earned an upfront license fee and will be eligible to earn milestone payments and royalties on commercial sales.
EP1013 is a di-peptide small molecule compound with potent and irreversible inhibitory effect on caspases, a class of enzymes critical for cell death and inflammatory response. Initial tests of EP1013 by EpiCept and Shanghai Genomics have shown promising efficacy in animal models of liver failure, brain ischemia, and myocardial infarction. EP1013 was discovered by EpiCept scientists and is covered by patents in the U.S., China, and other key markets.
Liver disease is a “national” disease in China with more than 20 million people affected by HBV virus infection. The late stage of HBV infections is characterized by the dysfunction of liver cells and eventual cell death. Although liver transplantation may help some patients, it is costly and requires a long waiting period. Inhibiting liver cell death may help the liver to recover function. A novel therapy for liver disease represents a large market opportunity for GNI in China and Japan. GNI intends to complete toxicology and PK studies to prepare for an IND filing with the Chinese SFDA as soon as possible.
Dr. Ying Luo, Chief Executive Officer of GNI and Shanghai Genomics, said, “Both in-house development and external co-development are important components of our R&D strategy. EP1013 is complementary to F351, our first drug candidate in Phase I trial for liver fibrosis. Developing these two products in Asia will establish us as a leading player in liver disease therapy.”