Gilead Sciences said Monday that it hopes to begin clinical trials this summer evaluating an inhaled formulation of remdesivir, administered via a nebuliser, to patients with COVID-19. The experimental antiviral, which the FDA authorized for emergency use in early May, is currently given intravenously through daily infusions to COVID-19 patients in hospital, but Gilead said the new formulation may allow for administration of the drug outside hospitals and at earlier stages of the disease.
According to CEO Daniel O’Day, “that could have significant implications in helping to stem the tide of the pandemic.” The company indicated that it will screen healthy volunteers for phase 1 testing this week, before moving on to patients with COVID-19, with clinical studies potentially starting in August.
The clinical trials conducted on remdesivir so far have focused on hospitalized patients. These include the ACTT trial run by the US National Institute of Allergy and Infectious Diseases, which found that remdesivir was linked to faster recovery times than placebo, particularly for those not on mechanical ventilation, as well as Gilead’s own SIMPLE study of moderately ill patients, which demonstrated that a 5-day course of remdesivir led to better clinical outcomes than standard care.
Earlier stages of disease and combinations
O’Day said that as part of the next phase of development, Gilead will also be looking to test intravenous infusions of remdesivir in earlier stages of COVID-19, including in outpatient settings such as infusion centres and nursing homes. “For patients who are at high risk of disease progression, it could be particularly beneficial to start treatment outside the hospital,” he said, adding “our hope is that earlier intervention could help patients avoid hospitalisation altogether.”
The company also wants to explore combining remdesivir with other therapies. Trials already under way include evaluating remdesivir with Eli Lilly’s JAK inhibitor Olumiant (baricitinib) and with Roche’s IL-6 inhibitor Actemra/RoActemra (tocilizumab), with results from these anticipated “over the coming months,” O’Day said. The executive remarked “we have been keen to explore how remdesivir might work when combined with anti-inflammatory agents, particularly in the most severely ill patients.” The CEO noted that recent data showing that dexamethasone significantly improved survival rates in hospitalised COVID-19 patients suffering from severe respiratory complications, “appears to further support the study of complementary approaches” for treating the disease.
Looking ahead, O’Day said Gilead also plans to conduct trials of remdesivir in vulnerable patient groups. Last week, the company announced that it would begin recruiting approximately 50 paediatric patients with moderate-to-severe COVID-19, including newborns through to adolescents. It is also collaborating with an external group on a study in pregnant women, and planning a trial for patients with end-stage renal disease.
Meanwhile, O’Day said the company has donated its entire existing supply of remdesivir through June, but expects to have more than 2 million treatment courses manufactured by the end of the year and “many millions more” by 2021. “Our scientists will stay focused on optimising the manufacturing process, and we will continue to collaborate globally to ensure sufficient worldwide supply,” he added. In May, Gilead signed non-exclusive licensing deals with multiple generic drugmakers to distribute remdesivir to 127, mostly low- and lower-middle income countries.