Cocrystal Pharma announced the of the first subjects in a Phase 1 clinical trial with its oral, first-in-class pan-norovirus and pan-coronavirus 3CL protease inhibitor CDI-988.
This pan-viral protease inhibitor was discovered using the Company’s proprietary structure-based drug discovery platform technology. The Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of oral CDI-988 in single ascending doses (SAD) including food effect cohort, and multiple ascending doses (MAD) compared to placebo in healthy volunteers.
“CDI-988 is a breakthrough discovery of the first-in-class pan-coronavirus and pan-norovirus antiviral agent with potential efficacy in these two indications and we excited to take the first step in its clinical development. Our oral antiviral candidate has the potential to save patient lives and reduce the severity of norovirus and coronavirus infections now and in future pandemic outbreaks,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We are looking forward to advancing CDI-988 to the next stage of norovirus and coronavirus clinical development upon completion of this Phase 1 study, setting up a transformational year ahead for Cocrystal.”
Recent CDI-988 in vitro studies showed potent broad-spectrum antiviral activity against a panel of pandemic GII.4 norovirus proteases and a favorable pharmacokinetic property targeting the gastrointestinal tract. GII.4 proteases have caused the majority of norovirus outbreaks worldwide since 2002 and represent an unmet medical need for an approved antiviral treatment and vaccine against noroviruses.
“We believe CDI-988 to be a gamechanger in providing an effective targeted, oral treatment for COVID-19 and its variants, as well as for noroviruses,” added James Martin, Cocrystal’s CFO and co-CEO. “There are no approved treatments or vaccines for norovirus, which has an annual estimated societal cost of $60 billion. Driven by the anticipated emergence of new COVID-19 variants, the global COVID-19 therapeutics market is estimated to exceed $16 billion by the end of 2031.
“In keeping with our corporate mission, this Phase 1 study with CDI-988 is being run cost-efficiently under the favorable regulatory environment and government incentive programs offered by the Australian government,” he added.
Human noroviruses are highly contagious, constantly evolving, extremely stable in the environment and associated with debilitating illness. Symptoms include vomiting and diarrhea, with or without nausea and abdominal cramps. Norovirus infection can be much more severe and prolonged in specific risk groups including infants, children, the elderly, and people with immunodeficiency. In the United States alone, noroviruses are responsible for an estimated 21 million cases of acute gastroenteritis annually, including 109,000 hospitalizations, 465,000 emergency department visits and nearly 900 deaths, according to the CDC. The National Institutes of Health (NIH) estimates the annual burden to the U.S. at $10.6 billion. Outbreaks occur most commonly in semi-closed communities such as nursing homes, hospitals, cruise ships, schools, disaster relief sites and military settings. To date, no antiviral treatment or vaccine is approved for norovirus infections.
CDI-988 was specifically designed and developed as a broad-spectrum antiviral inhibitor using Cocrystal’s proprietary structure-based drug discovery platform technology. It targets a highly conserved region in the active site of coronaviruses, noroviruses and other 3CL viral proteases. Cocrystal is approved to conduct a CDI-988 Phase 1 study in Australia by that country’s Human Research Ethics Committee (HREC).
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