Cocrystal Pharma Receives FDA Fast Track Designation For CDI-988 To Advance Treatment And Prevention Of Norovirus Infections

Cocrystal Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CDI-988, its oral, direct-acting protease inhibitor. CDI-988 is the first oral antiviral candidate being developed specifically for both treatment and prevention of norovirus infection.

The FDA’s Fast Track designation is intended to speed up the development and review of therapies for serious conditions with unmet medical needs. This status allows a company to engage in more frequent communication with the FDA, submit portions of a New Drug Application (NDA) on a rolling basis, and potentially qualify for Priority Review once the NDA is filed. These advantages can help bring promising treatments to patients more quickly.

CDI-988 was created using a structure-based design approach to inhibit a highly conserved region shared among noroviruses, coronaviruses, and other viral 3CL proteases, making it a potential pan-viral antiviral candidate. A Phase 1b norovirus challenge study is currently underway at Emory University School of Medicine to evaluate CDI-988 for both prevention and treatment of norovirus infection.

Sam Lee, Ph.D., President and co-CEO of the company, said that receiving Fast Track designation represents an important milestone in advancing CDI-988 and highlights the need for new options to help patients affected by norovirus. He explained that norovirus is extremely contagious and can cause acute gastroenteritis, leading to symptoms such as nausea, vomiting, abdominal pain, diarrhea, fatigue, fever, and dehydration. While most individuals recover within a short period, those who are immunocompromised may suffer from persistent infections lasting weeks to years. Based on the encouraging data gathered so far, he believes CDI-988 shows strong potential to address both prevention and treatment needs.

Dr. Lee added that the designation supports the company’s strategy of applying its structure-based drug discovery technology to develop broad-acting antiviral treatments. He noted that Cocrystal looks forward to ongoing communication with the FDA and remains focused on progressing CDI-988 with the goal of delivering the first therapeutic and preventive solution for norovirus infections.