ContraVir Pharmaceuticals Inc (NASDAQ:CTRV) announced that it will begin its first clinical studies for its drug CRV431 after the US Food and Drug Administration accepts its Investigational New Drug application.
Clinical development will begin on CRV431, which is intended to reduce the size of liver tumors in patients with hepatitis B by inhibiting cyclophilin isomerase activity. Viruses use cyclophilin to replicate themselves.
Hepatocellular carcinoma is the most common type of primary liver cancer in people and the leading cause of death in people with cirrhosis.
“The FDA’s approval of our development strategy in accelerating the clinical development of CRV431 allows us to move into patient trials in an expedited manner,” said CEO James Sapirstein in a press release.
The partially-blind, placebo-controlled study will be conducted in the U.S. with participation from hepatitis B patients.
Study design is key
Maxim analysts viewed the FDA approval as a pathway to an accelerated timeline.
The trial is set up in three parts and will test healthy subjects as well as patients with hepatitis B. This design may eliminate a need for separate single drug studies and the company can instead move straight to combination studies.
Maxim analysts maintained a Hold rating on the biotech.
Shares of the New Jersey-based company were up more than 4% to US$1.51 Thursday afternoon after jumping as high as 15% in early trading.
--Updated to include analyst note