COCP: Cocrystal Pharma doses 1st subjects in the important CDI-988 clinical trial.
NASDAQ:COCP
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On September 23, 2023, Cocrystal Pharma (NASDAQ:COCP) announced the dosing of the first subjects in its 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. There will be approximately 80 subjects for this trial.
Dr. Sam Lee, Cocrystal’s President and co-CEO stated, “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 are 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. 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.
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 U.S., 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 Centers for Disease Control and Prevention (CDC). The National Institutes of Health (NIH) estimates the annual cost burden to the U.S. at approximately $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.
James Martin, Cocrystal’s CFO and co-CEO stated, “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. 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.”
Regarding the company’s novel oral PB2 inhibitor, CC-42344, which targets Influenza A, the company submitted an application to the United Kingdom Medicines and Healthcare Products Regulatory Agency to conduct the Phase 2a human challenge study and, pending clearance, is expected to initiate the study at the end of 2023. In addition, preclinical development is underway with an inhaled formulation of CC-42344 as a treatment and prophylaxis for influenza A. Phase 1 clinical trial for this is expected to commence in the 1st half of 2024.
The company’s current cash position of $32.4 million should be sufficient to fund its operations through the 2nd quarter of 2024, depending on R&D spending levels and possible milestone payments from Merck. There are no changes to our estimates at this time as we await 3rd quarter 2023 financial results.
We are maintaining our price target of $7.00 per share based on higher prevailing interest rates affecting our discounted cash flow calculation as well as uncertainty related to the timing of receiving Merck milestone payments.
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