08 Jun 2020
Posted in Coronavirus
Gilead’s remdesivir gets MHRA green light, but only targets select group of COVID-19 patients
GlobalData anticipates that Gilead’s remdesivir will target a select severity group of COVID-19 patients, and it remains questionable as to how treatment with the drug will be initiated and optimized.
Angad Lotay MPharm, Infectious Diseases Analyst at GlobalData, states: “Gilead’s remdesivir was trialled in a number of patients with varying severities, however, it was noted that the drug did not provide benefit to mild or critically ill COVID-19 patients who required ventilation or extracorporeal membrane oxygenation. Hospitals are therefore limited to targeting a select population of moderate to severe patients.
“Furthermore, the latest evidence did not provide guidance on how to optimize treatment or whether earlier initiation with remdesivir reduces mortality rates. With additional data from Gilead’s SIMPLE trial expected, patients with the highest unmet medical needs are still left without an optimal treatment option”.
Remdesivir has a broad spectrum anti-viral activity and acts as a viral RNA polymerase inhibitor. However, it exerts minimal cytokine responses necessary to manage patients who are critically ill and require ventilatory support. In a bid to target this population, Gilead has been testing remdesivir with immune modulators to tackle the enormous immune reactions that strike patients in the latter stages of this disease. Roche is the latest member to enter this partnership and has launched a Phase III clinical trial in severe COVID-19 associated pneumonia. The trial named REMDACTRA will test Roche’s IL-6 inhibitor Actemra (tocilizumab) with Gilead’s remdesivir in a randomized double blind, multi-contre trial comparing the safety and efficacy of the combination versus remdesivir plus placebo.
In a previous Phase II single arm study, tocilizumab showed modest potential after decreasing abnormally elevated C-reactive protein in 84% of subjects. Although the trial lacked significant numbers of participants and was not a robust study, GlobalData anticipates that combining tocilizumab with remdesivir will undoubtedly provide better outcomes for critically ill COVID-19 patients.
Lotay adds: “The extent of these outcomes will only be revealed following the completion of the Phase III REMACTRA trial which is now expected to start enrolling patients in June. Furthermore, Roche is also enrolling patients in another Phase III trial COVACT (NCT04320615) which aims to evaluate the safety and efficacy of tocilizumab as monotherapy in severely unwell COVID-19 patients. The data from REMDACTRA and COVACT will be of great use to establish whether tocilizumab is the correct partner for remdesivir when treating the most critically ill COVID-19 patients”.