Cocrystal Pharma Receives FDA IND Clearance for Challenge Study of Oral Broad-Spectrum Protease Inhibitor CDI-988, a Potential First Antiviral for Norovirus Prevention and Treatment

Core Viewpoint - Cocrystal Pharma has received FDA approval to proceed with a Phase 1b challenge study for CDI-988, an oral antiviral candidate aimed at preventing and treating norovirus infections, which is a significant milestone for the company [1][3]. Company Overview - Cocrystal Pharma, Inc. is a clinical-stage biotechnology company focused on developing innovative antiviral treatments for diseases such as influenza, viral gastroenteritis, COVID, and hepatitis [6]. - The company utilizes a proprietary structure-based drug discovery platform to create first- and best-in-class antiviral drugs [5][6]. Product Details - CDI-988 is a novel pan-viral 3CL protease inhibitor designed for norovirus and coronavirus infections, demonstrating broad-spectrum antiviral activity [2]. - Preclinical data indicates that CDI-988 effectively targets major norovirus proteases, including GII.4 and GII.17, and has shown a favorable safety profile in Phase 1 studies [2][3]. - Currently, there are no approved vaccines or therapeutics for norovirus infections, making CDI-988 the first antiviral candidate for this purpose [8]. Industry Context - Norovirus infections are a significant public health issue, causing an estimated 21 million infections annually in the U.S., leading to 109,000 hospitalizations and approximately 900 deaths [4]. - The virus spreads rapidly in confined environments, complicating containment efforts, particularly among vulnerable populations [4].