Codivir, a short synthetic 16 amino-acid peptide, derived from the HIV-1 integrase, was originally discovered at the Hebrew University in Israel.
Code Pharma discovered that the peptide had a direct antiviral effect against SARS-CoV-2, the novel Coronavirus causing COVID-19. In-vitro studies conducted at the British virology research laboratory Virology Research Services in London then demonstrated a potent antiviral activity against SARS-CoV-2 and other RNA viruses.
Subsequently, a phase I clinical trial of Codivir in patients with COVID-19 was approved in Brazil by the National Research Ethics Commission (CONEP). The trial was conducted at Casa de Saúde – Vera Cruz Hospital in São Paulo, Brazil, with Dr Florentino Cardoso as the principal investigator. The results of the study showed that Codivir has a high safety profile while significantly suppressing viral replication in most of the fully assessed patients with an antiviral effect noted as early as three days. All patients recovered quickly after the treatment with Codivir and didn't show any signs of side effects very often associated with COVID-19 infections. Manuscripts describing these results have been submitted to a peer-reviewed journal.
Dr YotamKolben and Dr AsaKesler, from the Department of Medicine at Hadassah Medical Center, who are the lead authors on the paper stated: "The preclinical data, and the results of the clinical trial support the safety of Codivir administration in humans and suggest its significant anti-COVID-19 effect. Using a direct anti-viral drug carries the potential for improving the current therapies available for COVID-19".
These results indicate that the drug can be used to treat COVID-19 patients suffering at different levels of severity. Due to its direct anti-viral effect, Codivir may have a similar beneficial effect on other RNA viruses, such as influenza.
Following the successful phase I study, the company is now initiating a phase II double-blind controlled study, to be conducted in Spain, Brazil, South Africa, and Israel, with a larger cohort. In view of the ongoing global pandemic, Code Pharma has submitted emergency approval requests to several countries. To answer the expected demand, the company is preparing for mass production of Codivir in different sites worldwide.
"In the first and second wave of the COVID-19 pandemic, most drugs with putative or proven antiviral mechanisms of action have not proven themselves to significantly prolong life expectancy", Prof Shlomo L. Maayan, Director Infectious Disease division at the Barzilai Medical Center in Ashkelon, said. "'Codivir' has a very good safety profile and a very impressive antiviral effect, both in laboratory conditions and in phase I clinical trial in humans. We eagerly await the results of the double-blind studies using Codivir. It may be a breakthrough in the field of antiviral therapy for COVID-19 patients".