5 czerwca, 2020

Clinical trials for COVID-19 – update #7

After 6 months of the epidemic amongst 190 countries, more than 6,5 million people have fallen ill of COVID-19, the viral disease caused by SARS-CoV-2and about 400,000 of them have died. Until now, there are more than 2,000 clinical trials, which are planned, ongoing, or completed, are concerned with COVID-19.

Drugs

RFL-100

Relief Therapeutics and NeuroRx submitted the investigational new drug application (IND) with the U.S. Food and Drug Administration’s Coronavirus Treatment Accelerating Program (CTAP). They are going to perform a Phase II/III of a clinical trial investigating inhaled RFL-100 as a treatment for patients with non-acute lung injury caused by SARS-CoV-2.

RFL-100, known also as an Aviptadil is a synthetic human vasoactive intestinal polypeptide (VIP). It is known in animal models to inhibit inflammatory cytokines and to protect pulmonary epithelial cells that line the air sacs (alveoli) of the lung. The scientist’s findings suggest that the type-2 alveolar cells are particularly vulnerable to SARS-CoV-2 because of cell surface receptors that allow the virus to enter the cell. The type-2 cells are essential to replenishing the pulmonary epithelium and to manufacturing surfactant, which coats the inside of the lung and allows oxygen exchange to occur. Without surfactant, the alveoli fail to remain open and blood oxygen rapidly drops as in the case of COVID-19 patients.

LY-CoV555

Eli Lilly has started dosing participants in their Phase I of the clinical study of antibody therapy LY-CoV555, which is intended to treat the COVID-19 infection. This will be the first study to assess an antibody treatment for the disease. Lilly developed the antibody in three months after AbCellera and the National Institute of Allergy and Infectious Diseases (NIAID)’s Vaccine Research Center discovered it from a blood sample of one of the first patients who recovered from COVID-19 in the US.

LY-CoV555 is designed to specifically target SARS-CoV-2 as it is a neutralising IgG1 monoclonal antibody (mAb), directed against the spike protein of the virus. The first patients in the candidate’s Phase I trial have been enrolled at medical centres in the US, including New York University Grossman School of Medicine and Cedars-Sinai in Los Angeles.

Summary

Experts have suggested that the completion of clinical trials in COVID-19 will increase because more and more new approaches of the drugs targeting this disease have been discovered. To add to this, in the last few days, the European Medicines Agency (EMA) has held discussions on the approval of remdesivir as discussed in our previous updates HERE.

References

  1. https://www.trialsitenews.com/relief-therapeutics-submits-ind-for-phase-2-3-clinical-trial-of-rlf-100-targeting-early-covid-19-lung-injury/
  2. https://de.reuters.com/article/brief-relief-therapeutics-to-test-rlf-10/brief-relief-therapeutics-to-test-rlf-100-for-treatment-of-covid-induced-ards-idUKFWN2B91WW
  3. https://relieftherapeutics.com/relief-therapeutics-and-neurorx-announce-final-manufacturing-validation-of-rlf-100-for-phase-2b3-clinical-trial-in-patients-with-covid-19-associated-acute-respiratory-distress-syndrome/
  4. https://www.clinicaltrialsarena.com/news/lilly-covid-19-antibody-therapy/
  5. https://www.fiercebiotech.com/biotech/lilly-starts-first-clinical-trial-covid-19-antibody-therapy
  6. https://investor.lilly.com/news-releases/news-release-details/lilly-begins-worlds-first-study-potential-covid-19-antibody

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