• FDA Fast Track designation supports accelerated development and expedites regulatory review
• Norovirus is responsible for an estimated 685 million global cases each year and approximately $60 billion in worldwide economic impact

 Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its oral, direct-acting protease inhibitor, CDI-988, the first oral antiviral candidate being developed for treatment and prophylaxis of norovirus infection.

FDA Fast Track designation aims to facilitate the development and accelerate the review process for drugs that treat serious conditions and address unmet medical needs. The designation enables early and frequent communication with the FDA throughout the development process, allows for rolling review of a New Drug Application (NDA), and may qualify a product for Priority Review at the time of NDA submission.

CDI-988 was designed and developed as an inhibitor of a highly conserved region of noroviruses, coronaviruses, and other 3CL viral proteases. A Phase 1b norovirus challenge study is underway at Emory University School of Medicine to evaluate CDI-988 to both prevent and treat norovirus infection.

“We are pleased that the FDA has granted Fast Track designation for CDI-988, marking a significant milestone for Cocrystal and a critical step toward helping patients with norovirus,” said Sam Lee, Ph.D., President and co‑CEO of Cocrystal Pharma. “Norovirus infections are highly contagious and can cause acute gastroenteritis, resulting in nausea, vomiting, stomach pain, diarrhea, fatigue, fever and dehydration. While most people recover within a few days, immunocompromised individuals can experience chronic, long-term norovirus infections that can persist for weeks to years. Based on compelling data generated to date, we believe that CDI-988 has the potential to both prevent and treat norovirus infection.

“This designation further validates using our unique structure-based drug discovery technology to design pan-viral antivirals that are effective new treatment options,” added Dr. Lee. “We look forward to more frequent interactions with the FDA with the goal of delivering the first therapeutic and preventive medicine to treat norovirus infections.”