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Gilead’s coronavirus hopeful remdesivir shows early promise

Experts urge caution over the limited study data

Gilead

Gilead has revealed new data evaluating its experimental antiviral remdesivir in 53 COVID-19 patients who received the drug via a compassionate use programme.

The early data, which was published in the New England Journal of Medicine, analysed the drug’s efficacy among patients hospitalised with severe complications of COVID-19, who received the drug on an individual compassionate use basis.

Nearly two-thirds of patients (64%) were on mechanical ventilation at baseline, including four patient who were also on extracorporeal membrane oxygenation (ECMO).

This initial data shows promise, with 68% of patients receiving remdesivir experiencing an improvement in oxygen support class over a median follow-up of 18 days from the first dose.

Over half of all patients on mechanical ventilation were extubated and nearly half of all patients (47%) were discharged from hospital following treatment with Gilead’s drug.

After 28 days of follow-up, cumulative incidence of clinical improvement was 84%, according to Kaplan-Meier analysis. However, clinical improvement was less frequent among patients on invasive ventilation versus noninvasive ventilation, and among patients at least 70 years of age.

Although the compassionate use data shows early promise, Gilead has also said that the results have limitations, due to the small size of the cohort and the ‘relatively short’ follow-up time, as well as potential missing data due to the nature of the programme and a lack of a randomised control group.

J.P. Morgan analyst Cory Kasimov also urged caution, writing in a note on Monday that ‘the results need to be kept in context. It’s difficult, if not impossible, to make any firm conclusions from an uncontrolled data set with a small sample size’.

A number of larger clinical trials are underway in the US and China testing remdesivir’s efficacy against COVID-19, with the first data from two trials in China expected to be published this month.

Gilead is also expected to share the results from two phase 3 trials of the experimental drug in moderate and severe COVID-19 patients in May.

Remdesivir has been in the spotlight as a potential COVID-19 treatment since February, when Gilead announced that it had provided the drug for use in a small number of patients in China.

The drug was originally being developed as a treatment for a range of infectious disease including Ebola and SARS – another type of coronavirus.

Meanwhile, Eli Lilly has partnered with the National Institute of Allergy and Infectious Diseases (NIAID) in the US to study its oral JAK1/2 inhibitor baricitinib in hospitalised COVID-19 patients.

The hope is that baricitinib’s anti-inflammatory activity could have benefit against the extreme inflammatory response seen in COVID-19 patients. Novartis and Incyte are also assessing their JAK inhibitor ruxolitinib in severely-ill COVID-19 patients with cytokine storm, a form of inflammatory response to the virus.

Lilly is also advancing LY3127804, an investigational selective monoclonal antibody against Angiopoietin 2 (Ang2), into phase 2 testing in pneumonia patients hospitalised with COVID-19 who are at a higher risk of progressing to acute respiratory distress syndrome (ARDS).

Article by
PMGroup

14th April 2020

From: Research

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