- Topline single ascending dose (SAD) Phase 1 results of oral CDI-988, the first potential pan-coronavirus-pan-norovirus oral antiviral, expected in the second quarter of 2024
- Enrollment completed in Phase 2a influenza A human challenge study of oral CC-42344, with topline results expected in the second half of 2024
- FDA pre-IND feedback for oral CC-42344 received in first quarter of 2024 provides better clarity on late-stage trial design
- Initiation of Phase 1 study of inhaled CC-42344, a potential influenza treatment and post-exposure prophylactic, planned for the second half of 2024
“The coming months promise to be exceptionally eventful with major inflection points in our dual norovirus-coronavirus and influenza programs expected this year,” said
“In our Phase 2a human challenge study with our novel broad-spectrum oral PB2 inhibitor CC-42344 for pandemic and seasonal influenza A, we expect to report topline results and to prepare an IND application to conduct a late-stage clinical study in the
“We continue advancing our development programs in high-value indications through a cost-efficient business model,” said
Antiviral Product Pipeline Overview
We apply our proprietary structure-based drug discovery platform technology for developing broad-spectrum antivirals that inhibit the viral replication. By designing and selecting antiviral drug candidates that target the highly conserved regions of the viral enzymes, we seek to develop drugs that are effective against the virus and mutations of the virus, and also have reduced off-target interactions that may cause undesirable side effects. Our drug discovery process differs from traditional, empirical medicinal chemistry approaches that often require iterative high-throughput compound screening and lengthy hit-to-lead processes.
Influenza Programs
Influenza is a major global health threat that may become more challenging to treat in the future due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Each year there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deaths, according to the
- Oral CC-42344 for the treatment of pandemic and seasonal Influenza A infections
- Our novel PB2 inhibitor CC-42344 has shown excellent in vitro antiviral activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®.
- In
March 2022 we initiated enrollment in a randomized, double-blind, dose-escalating Phase 1 study to evaluate the safety, tolerability and pharmacokinetics (PK) of oral CC-42344 in healthy adults. - In
July 2022 we reported PK results from the SAD portion of the study that support once-daily dosing. - In
December 2022 we reported favorable safety and tolerability results from the oral CC-42344 Phase 1 study. - In
April 2023 we received approval fromUK MHRA for oral CC-42344 Phase 2a study. - In
December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, viral and clinical measurements of CC-42344 in influenza A infected subjects. - In
March 2024 we received feedback from the FDA on a Pre-IND package improving clarity on clinical trial design, drug manufacturing and nonclinical studies necessary to file a Phase 2b trial design. - In
May 2024 we completed enrollment in the Phase 2a human challenge study. - In the second half of 2024 we expect to report topline results from the Phase 2a human challenge study and to prepare an IND application to conduct a late-stage study in the
U.S.
- Inhaled CC-42344 for the treatment of pandemic and seasonal Influenza A infections
- GLP toxicology study is underway with inhaled CC-42344 as a potential therapeutic and post-exposure prophylaxis for influenza A. CC-42344 has exhibited superior pulmonary exposure in preclinical studies.
- We expect to begin a Phase 1 study with inhaled CC-42344 in
Australia in the second half of 2024.
- Influenza A/B Program
- Preclinical lead development of novel influenza replication inhibitors is underway.
COVID-19 and Other Coronavirus Programs
By targeting viral replication enzymes and protease, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). Our SARS-CoV-2 protease inhibitors showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses, and respiratory enteroviruses, as well as against noroviruses that can cause symptoms of acute gastroenteritis. Driven by the anticipated emergence of new COVID-19 variants, the global COVID-19 therapeutics market is estimated to exceed
Oral Pan -viral Protease Inhibitor CDI-988 for the treatment of coronaviruses and noroviruses- Our novel broad-spectrum protease inhibitor CDI-988 is being evaluated as a potential oral treatment for coronaviruses and noroviruses. CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and noroviruses, and demonstrated a favorable safety profile and PK properties.
- In
May 2023 we announced approval of our application to the Australian regulatory agency for a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability and PK of oral CDI-988 in healthy volunteers. - In
August 2023 we announced the selection of CDI-988 as our lead oral candidate for norovirus, in addition to coronavirus. - In
September 2023 we dosed the first subject in our dual norovirus-coronavirus oral CDI-988 study, which is expected to serve as a Phase 1 study for both indications. - We expect to report SAD cohort topline results from the Phase 1 study with CDI-988 in the second quarter of 2024.
Norovirus Program
Norovirus is a highly contagious infection and is the most common cause of acute gastroenteritis, accounting for nearly one in five cases. According to the
Oral Pan -viral Protease Inhibitor CDI-988 for the treatment of norovirus infection- CDI-988 has shown pan-viral activity against multiple norovirus strains, including the genogroup II, genotype 4 (GII.4) norovirus strain that is responsible for major norovirus outbreaks.
- In
August 2023 we announced our selection of the novel broad-spectrum oral 3CL protease inhibitor CDI-988 as our lead potential oral treatment for norovirus, in addition to coronavirus. - In
September 2023 we began dosing subjects in a first-in-human study in healthy volunteers inAustralia with oral CDI-988 that is expected to serve as a Phase 1 study for both indications. - We expect to report SAD cohort topline results from the Phase 1 study with CDI-988 in the second quarter of 2024.
First Quarter Financial Results
Research and development (R&D) expenses for the first quarter of 2024 were
Interest income for the first quarter of 2024 was
The net loss for the first quarter of 2024 was
Cocrystal reported unrestricted cash as of
About
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical drug candidates, our expectations regarding future characteristics of the product candidates we develop, the expected time of achieving certain value-driving milestones in our programs, including preparation, commencement and advancement of clinical studies for certain product candidates in 2024, the viability and efficacy of potential treatments for diseases our product candidates are designed to treat, expectations for the markets for certain therapeutics, our ability to execute our clinical and regulatory goals and deploy regulatory guidance towards future studies, and the expected sufficiency of our cash balance to advance our programs and fund our planned operations. The words "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from the high interest rates in response to inflation, uncertainty in the financial markets, the possibility of a recession and geopolitical conflict in
Investor Contact:
LHA Investor Relations
310-691-7100
jcain@lhai.com
Media Contact:
917-885-7378
Jabraham@jqapartners.com
Financial Tables to follow
CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited) | ||||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash | $ | 21,842 | $ | 26,353 | ||||||
Restricted cash | 75 | 75 | ||||||||
Tax credit receivable | 1,003 | 890 | ||||||||
Prepaid expenses and other current assets | 1,572 | 1,773 | ||||||||
Total current assets | 24,492 | 29,091 | ||||||||
Property and equipment, net | 244 | 271 | ||||||||
Deposits | 46 | 46 | ||||||||
Operating lease right-of-use assets, net (including | 1,764 | 1,851 | ||||||||
Total assets | $ | 26,546 | $ | 31,259 | ||||||
Liabilities and stockholders’ equity | ||||||||||
Current liabilities: | ||||||||||
Accounts payable and accrued expenses | $ | 2,139 | $ | 3,022 | ||||||
Current maturities of operating lease liabilities (including | 240 | 240 | ||||||||
Total current liabilities | 2,379 | 3,262 | ||||||||
Long-term liabilities: | ||||||||||
Operating lease liabilities (including | 1,582 | 1,613 | ||||||||
Total long-term liabilities | 1,582 | 1,613 | ||||||||
Total liabilities | 3,961 | 4,875 | ||||||||
Commitments and contingencies | ||||||||||
Stockholders’ equity: | ||||||||||
Common stock, | 10 | 10 | ||||||||
Additional paid-in capital | 342,445 | 342,288 | ||||||||
Accumulated deficit | (319,870 | ) | (315,914 | ) | ||||||
Total stockholders’ equity | 22,585 | 26,384 | ||||||||
Total liabilities and stockholders’ equity | $ | 26,546 | $ | 31,259 |
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share data)
Three months ended | |||||||||
2024 | 2023 | ||||||||
Operating expenses: | |||||||||
Research and development | 2,950 | 3,907 | |||||||
General and administrative | 1,208 | 1,204 | |||||||
Total operating expenses | 4,158 | 5,111 | |||||||
Loss from operations | (4,158 | ) | (5,111 | ) | |||||
Other income (expense): | |||||||||
Interest income (expense), net | 220 | - | |||||||
Foreign exchange loss | (18 | ) | (78 | ) | |||||
Total other income (expense), net | 202 | (78 | ) | ||||||
Net loss | $ | (3,956 | ) | $ | (5,189 | ) | |||
Net loss per common share, basic and diluted | $ | (0.39 | ) | $ | (0.64 | ) | |||
Weighted average number of common shares, basic and diluted | 10,174 | 8,143 |
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Source:
2024 GlobeNewswire, Inc., source