Gilead plans to begin a Phase-1 clinical trial in August of an inhaled version of remdesivir for early-stage COVID-19 treatment outside of hospital settings. The drug is currently approved for daily intravenous administration in the hospital.
With an approval from the U.S. FDA in hand, Gilead hopes to begin a Phase-1 clinical trial in August of an inhaled version of remdesivir, the antiviral drug against novel coronavirus. The idea is to administer the inhaled formulation through a nebulizer, which is an easier route, thus potentially allowing patients to be treated outside of hospital settings and to give it at earlier stages of the disease, says an open letter by Daniel O’Day, the Chirman and CEO of Gilead. The drug is currently approved for daily intravenous administration in the hospital.
“For patients who are at high risk of disease progression, it could be particularly beneficial to start treatment outside the hospital. Our hope is that earlier intervention could help patients avoid hospitalisation altogether,” O’Day said in the letter.
Remdesivir has been approved for COVID-19 treatment through FDA’s emergency use authorizations and other access programs around the world.
Preliminary results of a clinical trial (ACTT-1) carried out by the U.S. National Institutes of Health found the drug to be beneficial in reducing the duration of hospital stay by a median of four days in patients who did not need ventilator support. On June 1, Gilead in a press release announced encouraging results of a Phase-3 SIMPLE trial of the drug in hospitalized patients with moderate COVID-19.
The SIMPLE trial found the 5-day remdesivir treatment group was “65% more likely to have clinical improvement at day 11” in moderately ill patients compared with the control arm that received only standard of care. The 10-day treatment arm did not see statistically significant improvement in patients’ clinical status.
While the drug acts against the virus, which is the main driver of illness in the early stages of the disease, the body’s heightened inflammatory response at later stages of the disease worsens the condition and can also prove fatal. Gilead is therefore planning to conduct a trial wherein it will combine Remdesivir with anti-inflammatory drugs to treat the most severely ill patients, the letter says.