Cocrystal Pharma Inc (NASDAQ:COCP) saw its shares rise 45.1% on Thursday following a regulatory development: the U.S. Food and Drug Administration has granted Fast Track designation to CDI-988, the company's investigational oral antiviral for norovirus infection.
The Fast Track designation is intended to help expedite the development and review of medicines for serious conditions with unmet medical needs. Specifically, the status allows for more frequent interactions with the FDA, permits a rolling review of a New Drug Application, and can make a product eligible for Priority Review when an NDA is submitted.
CDI-988 is being developed as the first oral antiviral candidate aimed at both treatment and prophylaxis of norovirus infection. The molecule was engineered to inhibit a highly conserved region of viral 3CL proteases that includes noroviruses, coronaviruses, and other related viruses.
According to Cocrystal, norovirus causes about 685 million cases worldwide each year and carries an estimated $60 billion in global economic impact. Infected individuals typically experience acute gastroenteritis with symptoms such as nausea, vomiting, abdominal pain, diarrhea, fatigue, fever and dehydration. Most people recover within a few days, but the company notes that immunocompromised patients may suffer chronic infections that can persist for weeks to years.
A Phase 1b norovirus challenge study is currently in progress at Emory University School of Medicine to assess CDI-988 for both preventive and therapeutic use against norovirus infection. The clinical stage of the program was cited in the company disclosure about the Fast Track award.
In response to the designation, Sam Lee, President and co-CEO of Cocrystal Pharma, said the company was pleased by the FDA's decision and characterized the Fast Track status as an important milestone in efforts to advance CDI-988 toward helping patients with norovirus.
Based in Bothell, Washington, Cocrystal Pharma focuses on structure-based antiviral therapeutics. The company's announcement combined the regulatory update with clinical program details and its assessment of the global burden posed by norovirus.
Key context in brief
- The FDA Fast Track designation provides enhanced communication with regulators, rolling NDA review, and potential Priority Review eligibility.
- CDI-988 targets a conserved region of viral 3CL proteases and is being studied for both prevention and treatment of norovirus.
- The clinical evaluation includes a Phase 1b norovirus challenge trial at Emory University School of Medicine.