Codivir
Codivir
Code Pharma[1] is developing a new therapeutic peptide (Codivir[2]) with antiviral activity (SARS-CoV-2 and Influenza) and for the treatment of HIV infection. Codivir[2] is a 16 amino-acid synthetic peptide that is based on a short amino acid sequence derived from the HIV-1 integrase enzyme. This peptide stimulates the integration of multiple HIV DNA copies into the host cell genomic DNA, to an extent that triggers the self-destruction of infected cells by apoptosis[3][4][5]. Usually the integration of HIV viral DNA into the host cell is tightly controlled and reaches only one or two copies per cell; Code Pharma’s Codivir[2] peptide disrupts this control for therapeutic advantage. Pre-clinical and clinical results in HIV patients are promising, showing a reduction in viral load along with a significant increase in CD4 cells.
The peptide is the only active ingredient in the formulation for subcutaneous administration.
Mechanism
On the same basis of mechanism, a cancer therapeutic approach was developed[6]: integrase-mediated induction of cell death, targeted to CD24-expressing cancer cells. The method includes targeted delivery of the Codivir[2] peptide and lentivirus particles expressing on the envelop a small fragment (scFv) of a human anti-CD24 antibody. CD24 is a surface protein expressed mostly in cancer cells and is very rarely found in normal cells. The lentivirus "brings" its own integrase, thereby "labeling" the cells and making them sensitive to integrase-derived cell-permeable peptide activity. The active ingredients in this therapy are targeted CD24 lentiviral particles for IM administration and the same peptide formulation for SC administration.
Peptide
The peptide was found to have also a direct antiviral effect on SARS-CoV-2 and Influenza virus, in a different mechanism of action from HIV. Several in vitro studies were conducted and demonstrated an antiviral activity for the peptide against these two viruses. For SARS-CoV-2 it was also found that the antiviral activity is at the early stages of infection, however post entry of the virus to the cell. Further investigation is ongoing.
Medical Use
Codivir[2] is administered by the patient himself twice a day via a subcutaneous (under the skin) injection. This is done with a short needle that the user places in a fold of skin. Very similar to an insulin injection. Most people experience this as a simple act. If necessary, the injection can be given by a roommate or carer. The drug is intended for corona patients with mild to moderate symptoms or complaints and is prescribed by the general practitioner. The standard course of Codivir[2] is 7 days.
Phase 1: Clinical Trial (Finalised)
Phase 1 Clinical Study of Codivir[2] in outpatients with COVID-19” was conducted in April 2021.[7] The study was approved in Brazil by the National Research Ethics Commission (CONEP).[8]
The result demonstrated that Codivir[2] has a high safety profile with minimum side effects. Efficacy results showed clinical improvement of all patients within 6-48 hours and significantly suppressing viral replication in most of the fully assessed patients with an antiviral effect noted as early as three days.
Phase 2: Clinical Trial (In progress)
Following the completion of Phase I clinical trials, Code Pharma[1][7] has continued to prepare double-blind Phase II trials among a larger study group in several countries worldwide. A number of countries have already granted Code Pharma[1] authorization for Codivir[2] in an accelerated emergency procedure. The required production facility for the drug is being prepared in line with this.
Reference
- ↑ 1.0 1.1 1.2 "Scientific Research Company". CodePharma. Retrieved 2021-12-08.
- ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 content. "Code Pharma BV: Antiviral Drug Codivir Shows Promising Effect Against COVID-19 | World Pharma Today". Retrieved 2021-12-08.
- ↑ Aviad Levin, Zvi Hayouka, Assaf Friedler & Abraham Loyter (2010). "Specific eradication of HIV-1 from infected cultured cells". AIDS Research and Therapy. BMC Biomedcentral. 7: 31. doi:10.1186/1742-6405-7-31. PMC 2933580. PMID 20723214.CS1 maint: Multiple names: authors list (link)
- ↑ Aviad Levin, Zvi Hayouka, Markus Helfer, Ruth Brack-Werner, Assaf Friedler, Abraham Loyter (21 April 2010). "Stimulation of the HIV-1 integrase enzymatic activity and cDNA integration by a peptide derived from the integrase protein". Biopolymers. Biopolymers 93(8): 740-751. 93 (8): 740–751. doi:10.1002/bip.21469. PMID 20517955.CS1 maint: Multiple names: authors list (link)
- ↑ Levin, Aviad; Hayouka, Zvi; Friedler, Assaf; Loyter, Abraham (2010-08-02). "Peptides derived from the HIV-1 integrase promote HIV-1 infection and multi-integration of viral cDNA in LEDGF/p75-knockdown cells". Virology Journal. 7: 177. doi:10.1186/1743-422X-7-177. ISSN 1743-422X. PMC 2924314. PMID 20678206.
- ↑ Shapira S, Finkelshtein E, Kazanov D. Naftali E, Stepansky I, Loyter A, Elbirt D, Hay-Levy M, Brazowski E, Bendy F, Dekel R, Hershkovitz D, Blachar A, Wolf I, Arber N. (2021). "Peptides derived from the HIV-1 integrase promote HIV-1 infection and multi-integration of viral cDNA in LEDGF/p75-knockdown cells". Oncogene. National Library of Medicine. 40 (22): 3815–3825. doi:10.1038/s41388-021-01779-5. PMC 8175240 Check
|pmc=value (help). PMID 33958722 Check|pmid=value (help).CS1 maint: Multiple names: authors list (link) - ↑ 7.0 7.1 Code Pharma (2021-11-01). "Phase 1 Clinical Study of Codivir in Outpatients With COVID-19".
- ↑ "Conselho Nacional de Saúde - Ética em Pesquisa". conselho.saude.gov.br. Retrieved 2021-12-08.
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