The FDA has granted Fast Track designation to Cocrystal Pharma for CDI-988, the first oral antiviral candidate to treat and prevent norovirus infection.
CDI-988 is a direct-acting protease inhibitor designed to inhibit a highly-conserved region in various 3CL viral proteases, including in noroviruses and coronaviruses. It is currently undergoing a phase 1b randomized, double-blind, placebo-controlled challenge study with the primary endpoint being the reduction in incidence of clinical symptoms.
Across the globe, there are around 685 million cases of norovirus annually. This includes 21 million in the U.S. alone, which lead to 109,000 hospitalizations and 900 deaths. In developing countries, the virus causes as many as 1.1 million hospitalizations and 218,000 pediatric deaths each year.