StemCell Therapy

As the global COVID-19 situation is rapidly changing, staying abreast with the latest news can be challenging. In this article, Sheraz Gul provides an overview of the broad range of potential treatments in development and discusses how the regulatory landscape can shift at any time.

IN EARLY AUGUST 2020, the World Health Organization (WHO) reported the number of confirmed cases of COVID-19 has exceeded 20 million including over 700,000 deaths. These staggering figures have come about despite global lockdown measures being in place for the past few months. The resulting flattening of confirmed cases and deaths is now being jeopardised because, as the lockdown measures are being relaxed, we are seeing a resurgence of cases in some locations. In order to prevent a possible second wave of COVID-19 cases and deaths, the wearing of masks in public places is now mandatory in many countries. At the start of August 2020, New Zealand, which had gone 102 days without recording a locally transmitted case of COVID-19, saw new cases emerging. This highlights that we are still vulnerable to the spread of the virus.

Thus far, no US Food and Drug Administration (FDA)-approved therapy for use to treat COVID-19 is available. In order to provide some respite, on 1 May 2020 the FDA, as part of its Coronavirus Treatment Acceleration Program (CTAP), issued an Emergency Use Authorization (EUA) for the investigational antiviral drug remdesivir to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalised with severe disease. Although there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, this investigational drug has been shown in a clinical trial to shorten the time to recovery in some patients. It is noteworthy that prior to this, on 28 March 2020, the FDA also issued an EUA for chloroquine and hydroxychloroquine. This was subsequently revoked on 15 June 2020, as the FDA considered that chloroquine and hydroxychloroquine no longer met the statutory criteria for the EUA. In conclusion, the use and revocation of COVID-19 drugs can change at any time, so referring to official guidance is essential.

A recent update of the US ClinicalTrials. gov website listed around 2,000 COVID-19 interventional studies that are underway, around 90 of which are now completed. These cover a broad range of potential treatments including: 1) antiviral drugs to prevent viruses from multiplying; 2) immunomodulators aimed at reducing the bodys own immune reaction to the virus; 3) neutralising antibody therapies to fight the virus (manufactured, animalsourced and blood-derived from people who have previously had COVID-19); 4) cell therapy products (cellular immunotherapies and other types of both autologous and allogeneic cells, such as stem cells, and related products); and 5) gene therapy products that modify or manipulate the expression of a gene or alter the biological properties of living cells for therapeutic use. This diversity of therapeutic approaches is important as it allows opportunities for all types of treatments to be discovered, whilst expanding our understanding of the disease. Bearing in mind the timescale to discover a therapy for any given disease, the scientific community has made major advances towards developing a COVID-19 therapy. We eagerly await the output of various clinical trials over the next few months with the expectation that some of these yield sufficiently efficacious and safe therapies that gain approval by the regulators.

As the global COVID-19 situation is rapidly changing, it is advisable to stay abreast with the latest news only from reputable sources (see suggested reading below).

Sheraz Gul is an expert in drug discovery with experience gained in academia (University of London), industry (GlaxoSmithKline Pharmaceuticals) and the largest applied research organisation in Europe (Fraunhofer Institute). He is also an adjunct lecturer at NUI-Galway, Ireland and scientific co-founder of Transcriptogen Ltd. He has co-ordinated work packages in drug discovery projects, which have attracted more than 7 million funding and has organised 42 drug discovery workshops since 2011 across the globe and trained 780 scientists

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COVID-19 therapies in the pipeline - Drug Target Review

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