相关临床试验
6
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2004
已完成
5
83.3%
招募中
1
16.7%
暂无批准数据
- Cocrystal Pharma has completed dosing the last participant in a placebo-controlled Phase 1b human challenge study of CDI-988, an oral norovirus protease inhibitor, at Emory University School of Medicine. - The trial uses the well-characterized Snow Mountain Virus strain and enrolled 40 subjects in isolated units, with symptoms and viral load as clear endpoints. - CDI-988 holds FDA fast track designation for norovirus treatment and prophylaxis, with preliminary results expected in late 2026 or early 2027. - Norovirus causes an estimated 685 million illnesses and $60 billion in global costs annually, yet no specific antiviral treatment currently exists.
- Cocrystal Pharma appointed Carol Brosgart, MD to its Board of Directors, effective August 12, 2026, bringing decades of antiviral therapy and epidemiology expertise. - Dr. Brosgart contributed to the development and FDA approval of Gilead's antiviral therapies Viread and Hepsera during more than a decade at the company. - Her clinical and scientific insights will support advancement of CDI-988 for norovirus and the broader antiviral pipeline, according to Chairman Roger Kornberg. - CEO James Sapirstein highlighted Dr. Brosgart's combination of clinical rigor and real-world drug development experience at this pivotal stage for the company.
- Cocrystal Pharma received IRB approval from Emory University School of Medicine to initiate a Phase 1b human challenge study with CDI-988, the first oral antiviral drug candidate for norovirus prevention and treatment. - The randomized, double-blind, placebo-controlled study will enroll up to 40 healthy subjects ages 18-49 and evaluate CDI-988's efficacy in reducing clinical symptoms and viral shedding. - CDI-988 targets the highly conserved 3CL protease region across all norovirus strains and addresses a significant unmet medical need, as no approved treatments or vaccines currently exist for norovirus infections. - Norovirus causes approximately 700 million cases globally and 21 million cases annually in the U.S., resulting in substantial healthcare burden and economic costs exceeding $60 billion worldwide.
- Cocrystal Pharma secured $13 million in funding to advance its antiviral therapeutics pipeline, with lead candidate CDI-988 demonstrating favorable safety and tolerability in Phase 1 trials at doses up to 800 mg for 10 days. - The FDA cleared CDI-988 for a Phase 1b human challenge study targeting norovirus infections, addressing a significant unmet medical need with no currently approved therapeutics and 685,000 global deaths annually. - CC-42344, the company's influenza A PB2 inhibitor, completed enrollment in a Phase 2a human challenge study with 78 participants, though the trial faced logistical challenges due to unexpectedly low infection rates. - The company's structure-based drug discovery platform enables rapid identification of novel binding sites and targets conserved viral regions, potentially offering efficacy against multiple pathogen strains including norovirus variants GII.4 and GII.17.
- Cocrystal Pharma's investigational drug CC-42344 demonstrated exceptional antiviral activity against the highly pathogenic 2024 Texas H5N1 avian influenza strain with an EC50 of 0.003 µM. - The novel PB2 inhibitor showed approximately 1,000-fold greater potency compared to Tamiflu (EC50 2.69 µM) in virology studies using the A/Texas/37/2024 strain. - The compound targets a highly conserved active site of the PB2 protein and is being developed as an oral treatment for pandemic and seasonal influenza infections. - With favorable Phase 1 safety data already established, CC-42344 represents a potential breakthrough in addressing the multibillion-dollar influenza market and pandemic preparedness concerns.
- Cocrystal Pharma's oral antiviral candidate CDI-988 demonstrates potent activity against emerging GII.17 norovirus variants, which have recently overtaken GII.4 as the most prevalent strain in the US and Europe. - The pan-viral protease inhibitor targets a highly conserved region in viral proteases, showing broad-spectrum activity against both norovirus and coronavirus strains with a novel mechanism of action. - Following successful Phase 1 safety and tolerability results, Cocrystal plans to initiate a human challenge study in 2025 to evaluate CDI-988 as the first potential treatment and prevention option for norovirus infection.
- Cocrystal Pharma is extending its Phase 2a trial for CC-42344 due to unexpectedly low influenza infection rates among participants. - The Phase 2a study aims to evaluate the safety, tolerability, antiviral activity, and pharmacokinetics of CC-42344, an oral PB2 inhibitor. - CC-42344 has demonstrated a favorable safety and tolerability profile, with no serious adverse events or drug-related discontinuations reported. - The company is working to amend the study protocol to ensure adequate infection rates for accurate antiviral data analysis.
- Cocrystal Pharma anticipates topline results from its Phase 2a influenza A challenge study with oral PB2 inhibitor CC-42344 by year-end. - Cocrystal Pharma's Phase 1 pan-norovirus/pan-coronavirus study with oral protease inhibitor CDI-988 is progressing, with topline results expected in late 2024 or early 2025. - Chemomab Therapeutics plans to meet with the FDA to discuss the design of a CM-101 registrational trial for primary sclerosing cholangitis (PSC). - Chemomab's CM-101 Phase 2 SPRING trial data will be presented at the AASLD conference, with preparations underway for a Phase 3 trial in late 2025.
- Cocrystal Pharma's broad-spectrum antiviral CC-42344 demonstrated inhibitory activity against the highly pathogenic avian influenza A (H5N1) PB2 protein in recently completed in vitro studies. - The company is currently conducting a Phase 2a clinical trial with orally administered CC-42344 for influenza A treatment, with topline results expected in the second half of 2024. - Crystal structure analysis confirmed that CC-42344 binds to the highly conserved PB2 region of the avian H5N1 strain, similar to its activity against pandemic and seasonal influenza A viruses. - The findings are particularly significant given the recent CDC reports of H5N1 infections in farmworkers exposed to infected dairy cattle and the lack of specific FDA-approved vaccines for this virus in humans.
