Cocrystal Pharma has received investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) to conduct a Phase Ib challenge trial of pan-viral 3CL protease inhibitor CDI-988, designed to combat norovirus infections.
This therapy represents the first antiviral candidate aimed at preventing and treating viral gastroenteritis caused by norovirus, and is being developed to address norovirus and coronavirus infections.
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The company has scheduled the start of the challenge study for before the end of this year.
Cocrystal Pharma co-CEO and president Sam Lee said: “The FDA’s clearance of our CDI-988 study is an important milestone for Cocrystal and marks a significant step in advancing to the next stage of its clinical development.
“CDI-988 is the first novel, oral drug candidate for the prevention and treatment of norovirus infection and has demonstrated impressive data to date with broad antiviral activity. We look forward to the planned initiation of our Phase Ib challenge study and further determining the potential efficacy of CDI-988 in norovirus-infected patients.”
According to Cocrystal Pharma, preclinical studies have indicated that the therapy possesses broad-spectrum antiviral properties, targeting a conserved region within the active site of viral proteases.
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By GlobalDataIt has been effective against significant norovirus proteases, most notably the widespread GII.4 and GII.17 strains.
Results from an initial Phase I trial have demonstrated that oral administration of the therapy is well tolerated and has a favourable safety profile.
The development of CDI-988 is supported by the structure-based drug discovery platform of the company, which enables the three-dimensional visualisation of inhibitor complexes.
This technology is said to facilitate the detection of new drug binding sites and expedite the creation of antivirals for the management of acute and chronic viral conditions.
Cocrystal Pharma develops antiviral treatments for viral gastroenteritis, Covid-19, hepatitis, and influenza using its structure-based drug development technologies.
In 2023, Cocrystal secured approval from the Australian Human Research Ethics Committee (HREC) to initiate a Phase I trial of CDI-988 for the treatment of Covid-19.
