Norovirus is a global unmet public health concern that is responsible for close to 90% of epidemic, non-bacterial outbreaks of gastroenteritis and causes an estimated 685 million cases worldwide annually. About 200 million cases are reported among children under age 5, leading to an estimated 50,000 child deaths every year, mostly in developing countries. Norovirus is highly contagious and causes symptoms such as nausea, vomiting, stomach pain, diarrhea, fatigue, fever and dehydration. It is notorious for its occurrence in closed environments including hospitals, nursing homes, childcare facilities and cruise ships.

There is currently no effective treatment or effective vaccine for norovirus, and the ability to curtail outbreaks is limited. Few companies, if any, are developing antiviral treatments for this disease. Because of the significant unmet medical need and the possibility of chronic norovirus infection in immunocompromised individuals, new antiviral therapeutic approaches may warrant an accelerated path to market.

By targeting viral replication, we believe it is possible to develop an effective treatment for all genogroups of norovirus. We are developing inhibitors of the RNA-dependent RNA polymerase and protease of norovirus. These enzymes are essential to viral replication and are highly conserved between noroviral genogroups. Therefore, an inhibitor of this enzyme might be an effective therapeutic treatment or short-term prophylactic agent when administered in a closed environment.

To learn more about norovirus, please visit the information page at the Centers for Disease Control and Prevention (CDC).

CDI-988 – Norovirus Protease Inhibitor

We are developing a novel protease inhibitor CDI-988 as an oral treatment of noroviruses as well as coronavirus, including SARS-CoV-2 and its variants. CDI-988 was specifically designed and developed as a broad-spectrum antiviral inhibitor using our proprietary structure-based drug discovery platform technology to a highly conserved region in the active site of noroviruses, coronaviruses and other 3CL viral proteases.

CDI-988 is being clinically evaluated in a Phase 1 trial for safety, tolerability and pharmacokinetics in a randomized, double-blind, placebo-controlled Phase 1 study being conducted in Australia.

Noro Polymerase and Protease Inhibitors

We continue to identify and develop non-nucleoside polymerase inhibitors using our proprietary structure-based drug design technology platform. In 2020, we entered into a License Agreement with the Kansas State University Research Foundation to further develop certain proprietary broad-spectrum antiviral compounds for humans to treat norovirus and coronavirus infections. Preclinical activities for our Norovirus program are currently under way.

Program Discovery Preclinical Phase 1 Phase 2 Phase 3
Norovirus & Coronavirus Oral Pan-viral Protease Inhibitor CDI-988
Discovery Phase complete
Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
Norovirus Replication Inhibitors
Discovery Phase in progress
Preclinical Phase not started
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started