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NEW DELHI: Gilead Sciences has said it will soon start clinical trials for inhaled formulation of its antiviral drug remdesivir used for the treatment of covid-19. The US drugmaker said the trials will begin in August.

“Remdesivir, our investigational antiviral medicine, is currently given to patients intravenously through daily infusions in the hospital,” Gilead Sciences said in a statement, adding that the inhaled formulation will be given through a nebulizer, which could potentially allow for easier administration outside the hospital at early stages of the disease.

This could have significant implications in helping stem the tide of the pandemic, it said.

“We have already learned a lot about how remdesivir works in a relatively short space of time. Remdesivir is now being used to treat patients through emergency use authorizations and other access programs around the world. And yet, we still have some way to go in exploring the full potential of remdesivir to help against covid-19.”

In the next wave of clinical development, the drug maker said it will study remdesivir in combination with other therapies and in additional patient groups.

So far, randomised controlled trials of remdesivir have been evaluating safety and efficacy in hospitalised patients.

In a study by the National Institute of Allergy and Infectious Diseases, it was found that remdesivir shortened recovery time by an average of four days and in the SIMPLE study of moderately ill patients–those in hospital but not requiring oxygen–individuals on a five-day course of remdesivir had better clinical outcomes than those receiving standard care.

The NIAID study also showed that treatment was most effective in patients who did not require ventilator support, supporting further study in patients in early stages of the disease. The totality of these data shows that remdesivir has the potential to be of meaningful benefit to patients with covid-19.

“The inhaled formulation studies are one means of exploring the use of remdesivir in the earlier stages of covid-19. We will also conduct trials using intravenous infusions in outpatient settings such as infusion centers and nursing homes. For patients who are at high risk of disease progression, it could be particularly beneficial to start treatment outside the hospital,”’said Daniel O’Day, chairman and chief executive, Gilead Sciences.

“Our hope is that earlier intervention could help patients avoid hospitalization altogether. Based on our knowledge of the disease so far, it seems that in the earlier stages of covid-19, the virus itself is the primary driver of illness,” he said, adding that in the later stages, the body’s inflammatory response may cause some of the most life-threatening aspects of the disease.

“We have been keen to explore how remdesivir might work when combined with anti-inflammatory agents, particularly in the most severely ill patients,” he said.

India’s Central Drugs Standard Control Organisation on 20 June approved manufacturing and marketing of remdesivir by Hetero and Cipla for “restricted emergency use” among hospitalised covid-19 patients.

Cipla has launched its generic version of remdesivir 100-mg vial under the brand name CIPREMI, while Hetero’s product will be sold as COVIFOR.

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